Patient-specific medical systems, devices, and methods

ABSTRACT

Systems and methods for designing and implementing patient-specific surgical procedures and/or medical devices are disclosed. In some embodiments, a method includes receiving a patient data set of a patient. The patient data set is compared to a plurality of reference patient data sets, wherein each of the plurality of reference patient data sets is associated with a corresponding reference patient. A subset of the plurality of reference patient data sets is selected based, at least partly, on similarity to the patient data set and treatment outcome of the corresponding reference patient. Based on the selected subset, at least one surgical procedure or medical device design for treating the patient is generated.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/342,439 entitled “PATIENT-SPECIFIC MEDICAL SYSTEMS, DEVICES, ANDMETHODS,” filed on Jun. 8, 2021, which is a continuation ofInternational Application No. PCT/US21/12065, entitled “PATIENT-SPECIFICMEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMS AND METHODS,”filed on Jan. 4, 2021, which is a continuation-in-part of U.S. patentapplication Ser. No. 17/124,822 entitled “PATIENT-SPECIFIC MEDICALPROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMS AND METHODS,” filed onDec. 17, 2020, and is also a continuation-in-part of U.S. patentapplication Ser. No. 16/735,222 (now U.S. Pat. No. 10,902,944) entitled“PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMSAND METHODS,” filed on Jan. 6, 2020, the disclosures of which areincorporated by reference herein in their entireties.

TECHNICAL FIELD

The present disclosure is generally related to designing andimplementing medical care, and more particularly to systems and methodsfor designing and implementing surgical procedures and/or medicaldevices.

BACKGROUND

Numerous types of data associated with patient treatments and surgicalinterventions are available. To determine treatment protocols for apatient, physicians often rely on a subset of patient data available viathe patient's medical record and historical outcome data. However, theamount of patient data and historical data may be limited, and theavailable data may not be correlated or relevant to the particularpatient to be treated. Additionally, although digital data collectionand processing power have improved, technologies using collected data todetermine optimal treatment protocols have lagged. For example,conventional technologies in the field of orthopedics may lack thecapability to draw upon large data sets to generate and optimizepatient-specific treatments (e.g., surgical interventions and/or implantdesigns) to achieve favorable treatment outcomes.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate various embodiments of systems,methods, and embodiments of various other aspects of the disclosure. Anyperson with ordinary skill in the art will appreciate that theillustrated element boundaries (e.g., boxes, groups of boxes, or othershapes) in the figures represent one example of the boundaries. It maybe that in some examples one element may be designed as multipleelements or that multiple elements may be designed as one element. Insome examples, an element shown as an internal component of one elementmay be implemented as an external component in another, and vice versa.Furthermore, elements may not be drawn to scale. Non-limiting andnon-exhaustive descriptions are described with reference to thefollowing drawings. The components in the figures are not necessarily toscale, emphasis instead being placed upon illustrating principles.

FIG. 1 is a network connection diagram illustrating a system forproviding patient-specific medical care, according to an embodiment.

FIG. 2 illustrates a computing device suitable for use in connectionwith the system of FIG. 1, according to an embodiment.

FIG. 3 is a flow diagram illustrating a method for providingpatient-specific medical care, according to an embodiment.

FIGS. 4A-4C illustrate exemplary data sets that may be used and/orgenerated in connection with the methods described herein, according toan embodiment. FIG. 4A illustrates a patient data set. FIG. 4Billustrates a plurality of reference patient data sets. FIG. 4Cillustrates similarity scores and outcome scores for the referencepatient data sets of FIG. 4B.

FIG. 5 is a flow diagram illustrating another method for providingpatient-specific medical care, according to an embodiment.

FIG. 6 is a partially schematic illustration of an operative setup andassociated computing systems for providing patient-specific medicalcare, according to an embodiment.

FIGS. 7A-7D illustrates an exemplary patient data set that may be usedand/or generated in connection with the methods described herein,according to an embodiment.

FIGS. 8A and 8B illustrate an exemplary virtual model of a patient'sspine that may be used and/or generated in connection with the methodsdescribed herein, according to an embodiment.

FIGS. 9A-1-9B-2 illustrate an exemplary virtual model of a patient'sspine in a pre-operative anatomical configuration and a correctedanatomical configuration. More specifically, FIGS. 9A-1 and 9A-2illustrates the pre-operative anatomical configuration of the patient,FIGS. 9B-1 and 9B-2 illustrates the corrected anatomical configuration.

FIG. 10 illustrates an exemplary surgical plan for a patient-specificsurgical procedure that may be used and/or generated in connection withthe methods described herein, according to an embodiment.

FIG. 11 illustrates an exemplary surgical plan report detailing thesurgical plan shown in FIG. 10 for surgeon review and that may be usedand/or generated in connection with the methods described herein,according to an embodiment.

FIGS. 12A and 12B illustrate an exemplary patient-specific implant thatcan be used and/or generated in connection with the methods describedherein, according to an embodiment.

FIG. 13 illustrates a segment of a patient's spine after severalpatient- specific implants have been implanted therein.

DETAILED DESCRIPTION

The present technology is directed to systems and methods for planningand implementing medical procedures and/or devices. For example, in manyof the embodiments disclosed herein, a method of providing medical careincludes comparing a patient data set of a patient to be treated with aplurality of reference patient data sets (e.g., data frompreviously-treated patients). The method can include selecting a subsetof the reference patient data sets, e.g., based on similarity of thereference patient data set to the patient data set and/or whether thereference patient had a favorable treatment outcome. The selected subsetcan be used to generate a surgical procedure and/or medical devicedesign that is likely to produce a favorable treatment outcome for theparticular patient. In some embodiments, the selected subset is analyzedto identify correlations between patient pathology, surgical procedures,device designs, and/or treatment outcomes, and these correlations areused to determine a personalized treatment protocol with a higherlikelihood of success.

In the context of orthopedic surgery, systems with improved computingcapabilities (e.g., predictive analytics, machine learning, neuralnetworks, artificial intelligence (AI)) can use large data sets todefine improved or optimal surgical interventions and/or implant designsfor a specific patient. The patient's entire data can be characterizedand compared to aggregated data from groups of prior patients (e.g.,parameters, metrics, pathologies, treatments, outcomes). In someembodiments, the systems described herein use this aggregated data toformulate potential treatment solutions (e.g., surgical plans and/orimplant designs for spine and orthopedic procedures) and analyze theassociated likelihood of success. These systems can further comparepotential treatment solutions to determine an optimal patient-specificsolution that is expected to maximize the likelihood for a successfuloutcome.

For example, if a patient presents with a spinal deformity pathologythat can be described with data including lumbar lordosis, Cobb angles,coronal parameters (e.g., coronal balance, global coronal balance,coronal pelvic tilt, etc.), sagittal parameters (e.g., pelvic incidence,sacral slope, thoracic kyphosis, etc.) and/or pelvic parameters, analgorithm using these data points as inputs can be used to describe anoptimal surgical plan and/or implant design to correct the subjectpathology and improve the patient's outcome. As additional data inputsare used to describe the pathology (e.g., disc height, segmentflexibility, bone quality, rotational displacement), the algorithm canuse these additional inputs to further define an optimal surgical planand/or implant design for that particular patient and their pathology.

In some embodiments, the present technology can automatically or atleast semi-automatically determine a corrected anatomical configurationfor a subject patient suffering from one or more deformities. Forexample, the computing systems described herein can apply mathematicalrules for select parameters (e.g., lumbar lordosis, Cobb angles, etc.)and/or identify similar patients by analyzing reference patient datasets, and, based on the rules and/or comparison to other patients, canprovide a recommended anatomical configuration that represents theoptimal outcome if the subject patient were to undergo surgery. In someembodiments, the systems and methods described herein generate a virtualmodel of the corrected/recommended anatomical configuration (e.g., forsurgeon review).

In some embodiments, the present technology can also automatically or atleast semi-automatically generate a surgical plan for achieving apreviously-identified corrected anatomical configuration for a subjectpatient. For example, based off the virtual model of the correctedanatomical configuration, the systems and methods herein can determine atype of surgery (e.g., spinal fusion surgery, non-fusion surgery, etc.),a surgical approach (e.g., anterior, posterior, etc.), and/or spinalparameters for the corrected anatomical configuration (e.g., lumbarlordosis, Cobb angels, etc.). The surgical plan can be transmitted to asurgeon for review and approval. In some embodiments, the presenttechnology can also design one or more patient-specific implants forachieving the corrected anatomical configuration via the surgical plan.

In some embodiments, the present technology provides systems and methodsthat generate multiple anatomical models of the patient. For example, afirst model may show the patient's native (e.g., pre-operative)anatomical configuration, and a second model may provide a simulation ofthe patient's corrected (e.g., post-operative) anatomical configuration.The second virtual model may optionally include one or more virtualimplants shown as implanted at one or more target regions of thepatient. Spine metrics (e.g., lumbar lordosis, Cobb angels, coronalparameters, sagittal parameters, pelvic parameters, etc.) can also beprovided for both the pre-operative anatomical configuration andexpected post-operative anatomical configuration.

In some embodiments, the present technology includes generating,designing, and/or providing patient-specific medical procedures formultiple locations within a patient. For example, the present technologycan include identifying at least two target regions or sites within apatient (e.g., a first vertebral level and a second vertebral level) forsurgical intervention. The present technology can then design at leasttwo patient-specific implants for implantation at the at least twotarget regions. The at least two patient-specific implants can each bespecifically designed for their respective target region, and thus canhave different geometries. In some embodiments, the corrected anatomicalconfiguration of the patient is only achieved by implanting each of theat least two patient-specific implants. In the context of spinalsurgery, for example, the present technology may provide a firstpatient-specific interbody device to be implanted between the L2 and L3vertebrae, a second patient-specific interbody device to be implantedbetween the L3 and L4 vertebrae, and a third patient-specific interbodydevice to be implanted between the L4 and L5 vertebrae.

In some embodiments, the present technology can predict, model, orsimulate disease progression within a particular patient to aid indiagnosis and/or treatment planning. The simulation can be done to modeland/or estimate future anatomical configurations and/or spine metrics ofthe patient (a) if no surgical intervention occurs, or (b) for a varietyof different surgical intervention options. The progression modeling canthus be used to determine the optimal time for surgical interventionand/or to select which surgical intervention provides the best long-termoutcomes. In some embodiments, the disease progression modelling isperformed using one or more machine learning models trained based on aplurality of reference patients.

In a particular non-limiting example, the present technology includes amethod for providing patient-specific medical care for a subjectpatient. The method can include receiving a patient-data set for thesubject patient that includes one or more images of the patient's spinalregion showing the patient's native anatomical configuration. The methodcan further include determining a corrected anatomical configuration forthe subject patient that is different than the native anatomicalconfiguration, and creating a virtual model of the corrected anatomicalconfiguration. The method can further include generating surgical planand designing one or more patient-specific implants for achieving thecorrected anatomical configuration in the subject patient. Inrepresentative embodiments, the foregoing method can be performed by asystem storing computer-executable instructions that, when executed,cause the system to perform the steps of method.

In a particular non-limiting example, the present technology includes amethod for designing a patient-specific orthopedic implant for a subjectpatient. The method can include receiving a patient data set of thesubject patient, the patient data set including spinal pathology datafor the subject patient. The patient data set can be compared to aplurality of reference patient data sets to identify one or more similarpatient data sets in the plurality of reference patient data sets, witheach identified similar patient data set corresponding to a referencepatient having similar spinal pathology to the subject patient and whoreceived treatment with an orthopedic implant. The method can furtherinclude selecting a subset of the one or more similar patient data setsbased on whether the similar patient data sets indicated the referencepatient had a favorable outcome following implantation of theirorthopedic implant. The method can further include identifying, for atleast one similar reference patients of the selected subset, surgicalprocedure data and design data for the respective orthopedic implantthat produced the favorable outcome in the similar reference patient.Based on the design data and the surgical produced data that producedthe favorable outcome in the similar reference patient, thepatient-specific orthopedic implant for the subject patient and asurgical procedure for implanting the patient-specific orthopedicimplant into the subject patient can be designed. In some embodiments,the method can further include outputting fabrication instructions forcausing a manufacturing system to manufacture the patient-specificorthopedic implant according to the generated design. In representativeembodiments, the foregoing method can be performed by a system storingcomputer-executable instructions that, when executed, cause the systemto perform the steps of method.

Embodiments of the present disclosure will be described more fullyhereinafter with reference to the accompanying drawings in which likenumerals represent like elements throughout the several figures, and inwhich example embodiments are shown. Embodiments of the claims may,however, be embodied in many different forms and should not be construedas limited to the embodiments set forth herein. The examples set forthherein are non-limiting examples and are merely examples among otherpossible examples.

The words “comprising,” “having,” “containing,” and “including,” andother forms thereof, are intended to be equivalent in meaning and beopen ended in that an item or items following any one of these words isnot meant to be an exhaustive listing of such item or items, or meant tobe limited to only the listed item or items.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural references unless the context clearly dictatesotherwise.

Although the disclosure herein primarily describes systems and methodsfor treatment planning in the context of orthopedic surgery, thetechnology may be applied equally to medical treatment and devices inother fields (e.g., other types of surgical practice). Additionally,although many embodiments herein describe systems and methods withrespect to implanted devices, the technology may be applied equally toother types of medical devices (e.g., non-implanted devices).

FIG. 1 is a network connection diagram illustrating a computing system100 for providing patient-specific medical care, according to anembodiment. As described in further detail herein, the system 100 isconfigured to generate a medical treatment plan for a patient. In someembodiments, the system 100 is configured to generate a medicaltreatment plan for a patient suffering from an orthopedic or spinaldisease or disorder, such as trauma (e.g., fractures), cancer,deformity, degeneration, pain (e.g., back pain, leg pain), irregularspinal curvature (e.g., scoliosis, lordosis, kyphosis), irregular spinaldisplacement (e.g., spondylolisthesis, lateral displacement axialdisplacement), osteoarthritis, lumbar degenerative disc disease,cervical degenerative disc disease, lumbar spinal stenosis, or cervicalspinal stenosis, or a combination thereof. The medical treatment plancan include surgical information, surgical plans, technologyrecommendations (e.g., device and/or instrument recommendations), and/ormedical device designs. For example, the medical treatment plan caninclude at least one treatment procedure (e.g., a surgical procedure orintervention) and/or at least one medical device (e.g., an implantedmedical device (also referred to herein as an “implant” or “implanteddevice”) or implant delivery instrument).

In some embodiments, the system 100 generates a medical treatment planthat is customized for a particular patient or group of patients, alsoreferred to herein as a “patient-specific” or “personalized” treatmentplan. The patient-specific treatment plan can include at least onepatient-specific surgical procedure and/or at least one patient-specificmedical device that are designed and/or optimized for the patient'sparticular characteristics (e.g., condition, anatomy, pathology,condition, medical history). For example, the patient-specific medicaldevice can be designed and manufactured specifically for the particularpatient, rather than being an off-the-shelf device. However, it shall beappreciated that a patient-specific treatment plan can also includeaspects that are not customized for the particular patient. For example,a patient-specific or personalized surgical procedure can include one ormore instructions, portions, steps, etc. that are non-patient-specific.Likewise, a patient-specific or personalized medical device can includeone or more components that are non-patient-specific, and/or can be usedwith an instrument or tool that is non-patient-specific. Personalizedimplant designs can be used to manufacture or select patient-specifictechnologies, including medical devices, instruments, and/or surgicalkits. For example, a personalized surgical kit can include one or morepatient-specific devices, patient-specific instruments,non-patient-specific technology (e.g., standard instruments, devices,etc.), instructions for use, patient-specific treatment planinformation, or a combination thereof.

The system 100 includes a client computing device 102, which can be auser device, such as a smart phone, mobile device, laptop, desktop,personal computer, tablet, phablet, or other such devices known in theart. As discussed further herein, the client computing device 102 caninclude one or more processors, and memory storing instructionsexecutable by the one or more processors to perform the methodsdescribed herein. The client computing device 102 can be associated witha healthcare provider that is treating the patient. Although FIG. 1illustrates a single client computing device 102, in alternativeembodiments, the client computing device 102 can instead be implementedas a client computing system encompassing a plurality of computingdevices, such that the operations described herein with respect to theclient computing device 102 can instead be performed by the computingsystem and/or the plurality of computing devices.

The client computing device 102 is configured to receive a patient dataset 108 associated with a patient to be treated. The patient data set108 can include data representative of the patient's condition, anatomy,pathology, medical history, preferences, and/or any other information orparameters relevant to the patient. For example, the patient data set108 can include medical history, surgical intervention data, treatmentoutcome data, progress data (e.g., physician notes), patient feedback(e.g., feedback acquired using quality of life questionnaires, surveys),clinical data, provider information (e.g., physician, hospital, surgicalteam), patient information (e.g., demographics, sex, age, height,weight, type of pathology, occupation, activity level, tissueinformation, health rating, comorbidities, health related quality oflife (HRQL)), vital signs, diagnostic results, medication information,allergies, image data (e.g., camera images, Magnetic Resonance Imaging(MRI) images, ultrasound images, Computerized Aided Tomography (CAT)scan images, Positron Emission Tomography (PET) images, X-Ray images),diagnostic equipment information (e.g., manufacturer, model number,specifications, user-selected settings/configurations, etc.), or thelike. In some embodiments, the patient data set 108 includes datarepresenting one or more of patient identification number (ID), age,gender, body mass index (BMI), lumbar lordosis, Cobb angle(s), pelvicincidence, disc height, segment flexibility, bone quality, rotationaldisplacement, and/or treatment level of the spine.

The client computing device 102 is operably connected via acommunication network 104 to a server 106, thus allowing for datatransfer between the client computing device 102 and the server 106. Thecommunication network 104 may be a wired and/or a wireless network. Thecommunication network 104, if wireless, may be implemented usingcommunication techniques such as Visible Light Communication (VLC),Worldwide Interoperability for Microwave Access (WiMAX), Long termevolution (LTE), Wireless local area network (WLAN), Infrared (IR)communication, Public Switched Telephone Network (PSTN), Radio waves,and/or other communication techniques known in the art.

The server 106, which may also be referred to as a “treatment assistancenetwork” or “prescriptive analytics network,” can include one or morecomputing devices and/or systems. As discussed further herein, theserver 106 can include one or more processors, and memory storinginstructions executable by the one or more processors to perform themethods described herein. In some embodiments, the server 106 isimplemented as a distributed “cloud” computing system or facility acrossany suitable combination of hardware and/or virtual computing resources.

The client computing device 102 and server 106 can individually orcollectively perform the various methods described herein for providingpatient-specific medical care. For example, some or all of the steps ofthe methods described herein can be performed by the client computingdevice 102 alone, the server 106 alone, or a combination of the clientcomputing device 102 and the server 106. Thus, although certainoperations are described herein with respect to the server 106, it shallbe appreciated that these operations can also be performed by the clientcomputing device 102, and vice-versa.

The server 106 includes at least one database 110 configured to storereference data useful for the treatment planning methods describedherein. The reference data can include historical and/or clinical datafrom the same or other patients, data collected from prior surgeriesand/or other treatments of patients by the same or other healthcareproviders, data relating to medical device designs, data collected fromstudy groups or research groups, data from practice databases, data fromacademic institutions, data from implant manufacturers or other medicaldevice manufacturers, data from imaging studies, data from simulations,clinical trials, demographic data, treatment data, outcome data,mortality rates, or the like.

In some embodiments, the database 110 includes a plurality of referencepatient data sets, each patient reference data set associated with acorresponding reference patient. For example, the reference patient canbe a patient that previously received treatment or is currentlyreceiving treatment. Each reference patient data set can include datarepresentative of the corresponding reference patient's condition,anatomy, pathology, medical history, disease progression, preferences,and/or any other information or parameters relevant to the referencepatient, such as any of the data described herein with respect to thepatient data set 108. In some embodiments, the reference patient dataset includes pre-operative data, intra-operative data, and/orpost-operative data. For example, a reference patient data set caninclude data representing one or more of patient ID, age, gender, BMI,lumbar lordosis, Cobb angle(s), pelvic incidence, disc height, segmentflexibility, bone quality, rotational displacement, and/or treatmentlevel of the spine. As another example, a reference patient data set caninclude treatment data regarding at least one treatment procedureperformed on the reference patient, such as descriptions of surgicalprocedures or interventions (e.g., surgical approaches, bony resections,surgical maneuvers, corrective maneuvers, placement of implants or otherdevices). In some embodiments, the treatment data includes medicaldevice design data for at least one medical device used to treat thereference patient, such as physical properties (e.g., size, shape,volume, material, mass, weight), mechanical properties (e.g., stiffness,strength, modulus, hardness), and/or biological properties (e.g.,osteo-integration, cellular adhesion, anti-bacterial properties,anti-viral properties). In yet another example, a reference patient dataset can include outcome data representing an outcome of the treatment ofthe reference patient, such as corrected anatomical metrics, presence offusion, HRQL, activity level, return to work, complications, recoverytimes, efficacy, mortality, and/or follow-up surgeries.

In some embodiments, the server 106 receives at least some of thereference patient data sets from a plurality of healthcare providercomputing systems (e.g., systems 112 a-112 c, collectively 112). Theserver 106 can be connected to the healthcare provider computing systems112 via one or more communication networks (not shown). Each healthcareprovider computing system 112 can be associated with a correspondinghealthcare provider (e.g., physician, surgeon, medical clinic, hospital,healthcare network, etc.). Each healthcare provider computing system 112can include at least one reference patient data set (e.g., referencepatient data sets 114 a-114 c, collectively 114) associated withreference patients treated by the corresponding healthcare provider. Thereference patient data sets 114 can include, for example, electronicmedical records, electronic health records, biomedical data sets, etc.The reference patient data sets 114 can be received by the server 106from the healthcare provider computing systems 112 and can bereformatted into different formats for storage in the database 110.Optionally, the reference patient data sets 114 can be processed (e.g.,cleaned) to ensure that the represented patient parameters are likely tobe useful in the treatment planning methods described herein.

As described in further detail herein, the server 106 can be configuredwith one or more algorithms that generate patient-specific treatmentplan data (e.g., treatment procedures, medical devices) based on thereference data. In some embodiments, the patient-specific data isgenerated based on correlations between the patient data set 108 and thereference data. Optionally, the server 106 can predict outcomes,including recovery times, efficacy based on clinical end points,likelihood of success, predicted mortality, predicted related follow-upsurgeries, or the like. In some embodiments, the server 106 cancontinuously or periodically analyze patient data (including patientdata obtained during the patient stay) to determine near real-time orreal-time risk scores, mortality prediction, etc.

In some embodiments, the server 106 includes one or more modules forperforming one or more steps of the patient-specific treatment planningmethods described herein. For example, in the depicted embodiment, theserver 106 includes a data analysis module 116 and a treatment planningmodule 118. In alternative embodiments, one or more of these modules maybe combined with each other, or may be omitted. Thus, although certainoperations are described herein with respect to a particular module ormodules, this is not intended to be limiting, and such operations can beperformed by a different module or modules in alternative embodiments.

The data analysis module 116 is configured with one or more algorithmsfor identifying a subset of reference data from the database 110 that islikely to be useful in developing a patient-specific treatment plan. Forexample, the data analysis module 116 can compare patient-specific data(e.g., the patient data set 108 received from the client computingdevice 102) to the reference data from the database 110 (e.g., thereference patient data sets) to identify similar data (e.g., one or moresimilar patient data sets in the reference patient data sets). Thecomparison can be based on one or more parameters, such as age, gender,BMI, lumbar lordosis, pelvic incidence, and/or treatment levels. Theparameter(s) can be used to calculate a similarity score for eachreference patient. The similarity score can represent a statisticalcorrelation between the patient data set 108 and the reference patientdata set. Accordingly, similar patients can be identified based onwhether the similarity score is above, below, or at a specifiedthreshold value. For example, as described in greater detail below, thecomparison can be performed by assigning values to each parameter anddetermining the aggregate difference between the subject patient andeach reference patient. Reference patients whose aggregate difference isbelow a threshold can be considered to be similar patients.

The data analysis module 116 can further be configured with one or morealgorithms to select a subset of the reference patient data sets, e.g.,based on similarity to the patient data set 108 and/or treatment outcomeof the corresponding reference patient. For example, the data analysismodule 116 can identify one or more similar patient data sets in thereference patient data sets, and then select a subset of the similarpatient data sets based on whether the similar patient data set includesdata indicative of a favorable or desired treatment outcome. The outcomedata can include data representing one or more outcome parameters, suchas corrected anatomical metrics, presence of fusion, HRQL, activitylevel, complications, recovery times, efficacy, mortality, or follow-upsurgeries. As described in further detail below, in some embodiments,the data analysis module 116 calculates an outcome score by assigningvalues to each outcome parameter. A patient can be considered to have afavorable outcome if the outcome score is above, below, or at aspecified threshold value.

In some embodiments, the data analysis module 116 selects a subset ofthe reference patient data sets based at least in part on user input(e.g., from a clinician, surgeon, physician, healthcare provider). Forexample, the user input can be used in identifying similar patient datasets. In some embodiments, weighting of similarity and/or outcomeparameters can be selected by a healthcare provider or physician toadjust the similarity and/or outcome score based on clinician input. Infurther embodiments, the healthcare provider or physician can select theset of similarity and/or outcome parameters (or define new similarityand/or outcome parameters) used to generate the similarity and/oroutcome score, respectively.

In some embodiments, the data analysis module 116 includes one or morealgorithms used to select a set or subset of the reference patient datasets based on criteria other than patient parameters. For example, theone or more algorithms can be used to select the subset based onhealthcare provider parameters (e.g., based on healthcare providerranking/scores such as hospital/physician expertise, number ofprocedures performed, hospital ranking, etc.) and/or healthcare resourceparameters (e.g., diagnostic equipment, facilities, surgical equipmentsuch as surgical robots), or other non-patient related information thatcan be used to predict outcomes and risk profiles for procedures for thepresent healthcare provider. For example, reference patient data setswith images captured from similar diagnostic equipment can be aggregatedto reduce or limit irregularities due to variation between diagnosticequipment. Additionally, patient-specific treatment plans can bedeveloped for a particular health-care provider using data from similarhealthcare providers (e.g., healthcare providers with traditionallysimilar outcomes, physician expertise, surgical teams, etc.). In someembodiments, reference healthcare provider data sets, hospital datasets, physician data sets, surgical team data sets, post-treatment dataset, and other data sets can be utilized. By way of example, apatient-specific treatment plan to perform a battlefield surgery can bebased on reference patient data from similar battlefield surgeriesand/or datasets associated with battlefield surgeries. In anotherexample, the patient-specific treatment plan can be generated based onavailable robotic surgical systems. The reference patient data sets canbe selected based on patients that have been operated on usingcomparable robotic surgical systems under similar conditions (e.g., sizeand capabilities of surgical teams, hospital resources, etc.).

The treatment planning module 118 is configured with one or morealgorithms to generate at least one treatment plan (e.g., pre-operativeplans, surgical plans, post-operative plans etc.) based on the outputfrom the data analysis module 116. In some embodiments, the treatmentplanning module 118 is configured to develop and/or implement at leastone predictive model for generating the patient-specific treatment plan,also known as a “prescriptive model.” The predictive model(s) can bedeveloped using clinical knowledge, statistics, machine learning, AI,neural networks, or the like. In some embodiments, the output from thedata analysis module 116 is analyzed (e.g., using statistics, machinelearning, neural networks, AI) to identify correlations between datasets, patient parameters, healthcare provider parameters, healthcareresource parameters, treatment procedures, medical device designs,and/or treatment outcomes. These correlations can be used to develop atleast one predictive model that predicts the likelihood that a treatmentplan will produce a favorable outcome for the particular patient. Thepredictive model(s) can be validated, e.g., by inputting data into themodel(s) and comparing the output of the model to the expected output.

In some embodiments, the treatment planning module 118 is configured togenerate the treatment plan based on previous treatment data fromreference patients. For example, the treatment planning module 118 canreceive a selected subset of reference patient data sets and/or similarpatient data sets from the data analysis module 116, and determine oridentify treatment data from the selected subset. The treatment data caninclude, for example, treatment procedure data (e.g., surgical procedureor intervention data) and/or medical device design data (e.g. implantdesign data) that are associated with favorable or desired treatmentoutcomes for the corresponding patient. The treatment planning module118 can analyze the treatment procedure data and/or medical devicedesign data to determine an optimal treatment protocol for the patientto be treated. For example, the treatment procedures and/or medicaldevice designs can be assigned values and aggregated to produce atreatment score. The patient-specific treatment plan can be determinedby selecting treatment plan(s) based on the score (e.g., higher orhighest score; lower or lowest score; score that is above, below, or ata specified threshold value). The personalized patient-specifictreatment plan can be based on, at least in part, the patient-specifictechnologies or patient-specific selected technology.

Alternatively or in combination, the treatment planning module 118 cangenerate the treatment plan based on correlations between data sets. Forexample, the treatment planning module 118 can correlate treatmentprocedure data and/or medical device design data from similar patientswith favorable outcomes (e.g., as identified by the data analysis module116). Correlation analysis can include transforming correlationcoefficient values to values or scores. The values/scores can beaggregated, filtered, or otherwise analyzed to determine one or morestatistical significances. These correlations can be used to determinetreatment procedure(s) and/or medical device design(s) that are optimalor likely to produce a favorable outcome for the patient to be treated.

Alternatively or in combination, the treatment planning module 118 cangenerate the treatment plan using one or more AI techniques. AItechniques can be used to develop computing systems capable ofsimulating aspects of human intelligence, e.g., learning, reasoning,planning, problem solving, decision making, etc. AI techniques caninclude, but are not limited to, case-based reasoning, rule-basedsystems, artificial neural networks, decision trees, support vectormachines, regression analysis, Bayesian networks (e.g., naïve Bayesclassifiers), genetic algorithms, cellular automata, fuzzy logicsystems, multi-agent systems, swarm intelligence, data mining, machinelearning (e.g., supervised learning, unsupervised learning,reinforcement learning), and hybrid systems.

In some embodiments, the treatment planning module 118 generates thetreatment plan using one or more trained machine learning models.Various types of machine learning models, algorithms, and techniques aresuitable for use with the present technology. In some embodiments, themachine learning model is initially trained on a training data set,which is a set of examples used to fit the parameters (e.g., weights ofconnections between “neurons” in artificial neural networks) of themodel. For example, the training data set can include any of thereference data stored in database 110, such as a plurality of referencepatient data sets or a selected subset thereof (e.g., a plurality ofsimilar patient data sets).

In some embodiments, the machine learning model (e.g., a neural networkor a naïve Bayes classifier) may be trained on the training data setusing a supervised learning method (e.g., gradient descent or stochasticgradient descent). The training dataset can include pairs of generated“input vectors” with the associated corresponding “answer vector”(commonly denoted as the target). The current model is run with thetraining data set and produces a result, which is then compared with thetarget, for each input vector in the training data set. Based on theresult of the comparison and the specific learning algorithm being used,the parameters of the model are adjusted. The model fitting can includeboth variable selection and parameter estimation. The fitted model canbe used to predict the responses for the observations in a second dataset called the validation data set. The validation data set can providean unbiased evaluation of a model fit on the training data set whiletuning the model parameters. Validation data sets can be used forregularization by early stopping, e.g., by stopping training when theerror on the validation data set increases, as this may be a sign ofoverfitting to the training data set. In some embodiments, the error ofthe validation data set error can fluctuate during training, such thatad-hoc rules may be used to decide when overfitting has truly begun.Finally, a test data set can be used to provide an unbiased evaluationof a final model fit on the training data set.

To generate a treatment plan, the patient data set 108 can be input intothe trained machine learning model(s). Additional data, such as theselected subset of reference patient data sets and/or similar patientdata sets, and/or treatment data from the selected subset, can also beinput into the trained machine learning model(s). The trained machinelearning model(s) can then calculate whether various candidate treatmentprocedures and/or medical device designs are likely to produce afavorable outcome for the patient. Based on these calculations, thetrained machine learning model(s) can select at least one treatment planfor the patient. In embodiments where multiple trained machine learningmodels are used, the models can be run sequentially or concurrently tocompare outcomes and can be periodically updated using training datasets. The treatment planning module 118 can use one or more of themachine learning models based the model's predicted accuracy score.

The patient-specific treatment plan generated by the treatment planningmodule 118 can include at least one patient-specific treatment procedure(e.g., a surgical procedure or intervention) and/or at least onepatient-specific medical device (e.g., an implant or implant deliveryinstrument). A patient-specific treatment plan can include an entiresurgical procedure or portions thereof. Additionally, one or morepatient-specific medical devices can be specifically selected ordesigned for the corresponding surgical procedure, thus allowing for thevarious components of the patient-specific technology to be used incombination to treat the patient.

In some embodiments, the patient-specific treatment procedure includesan orthopedic surgery procedure, such as spinal surgery, hip surgery,knee surgery, jaw surgery, hand surgery, shoulder surgery, elbowsurgery, total joint reconstruction (arthroplasty), skullreconstruction, foot surgery, or ankle surgery. Spinal surgery caninclude spinal fusion surgery, such as posterior lumbar interbody fusion(PLIF), anterior lumbar interbody fusion (ALIF), transverse ortransforaminal lumbar interbody fusion (TLIF), lateral lumbar interbodyfusion (LLIF), direct lateral lumbar interbody fusion (DLIF), or extremelateral lumbar interbody fusion (XLIF). In some embodiments, thepatient-specific treatment procedure includes descriptions of and/orinstructions for performing one or more aspects of a patient-specificsurgical procedure. For example, the patient-specific surgical procedurecan include one or more of a surgical approach, a corrective maneuver, abony resection, or implant placement.

In some embodiments, the patient-specific medical device design includesa design for an orthopedic implant and/or a design for an instrument fordelivering an orthopedic implant. Examples of such implants include, butare not limited to, screws (e.g., bone screws, spinal screws, pediclescrews, facet screws), interbody implant devices (e.g., intervertebralimplants), cages, plates, rods, disks, fusion devices, spacers, rods,expandable devices, stents, brackets, ties, scaffolds, fixation device,anchors, nuts, bolts, rivets, connectors, tethers, fasteners, jointreplacements, hip implants, or the like. Examples of instrumentsinclude, but are not limited to, screw guides, cannulas, ports,catheters, insertion tools, or the like.

A patient-specific medical device design can include data representingone or more of physical properties (e.g., size, shape, volume, material,mass, weight), mechanical properties (e.g., stiffness, strength,modulus, hardness), and/or biological properties (e.g.,osteo-integration, cellular adhesion, anti-bacterial properties,anti-viral properties) of a corresponding medical device. For example, adesign for an orthopedic implant can include implant shape, size,material, and/or effective stiffness (e.g., lattice density, number ofstruts, location of struts, etc.). In some embodiments, the generatedpatient-specific medical device design is a design for an entire device.Alternatively, the generated design can be for one or more components ofa device, rather than the entire device.

In some embodiments, the design is for one or more patient-specificdevice components that can be used with standard, off-the-shelfcomponents. For example, in a spinal surgery, a pedicle screw kit caninclude both standard components and patient-specific customizedcomponents. In some embodiments, the generated design is for apatient-specific medical device that can be used with a standard,off-the-shelf delivery instrument. For example, the implants (e.g.,screws, screw holders, rods) can be designed and manufactured for thepatient, while the instruments for delivering the implants can bestandard instruments. This approach allows the components that areimplanted to be designed and manufactured based on the patient's anatomyand/or surgeon's preferences to enhance treatment. The patient-specificdevices described herein are expected to improve delivery into thepatient's body, placement at the treatment site, and/or interaction withthe patient's anatomy.

In embodiments where the patient-specific treatment plan includes asurgical procedure to implant a medical device, the treatment planningmodule 118 can also store various types of implant surgery information,such as implant parameters (e.g., types, dimensions), availability ofimplants, aspects of a pre-operative plan (e.g., initial implantconfiguration, detection and measurement of the patient's anatomy,etc.), FDA requirements for implants (e.g., specific implant parametersand/or characteristics for compliance with FDA regulations), or thelike. In some embodiments, the treatment planning module 118 can convertthe implant surgery information into formats useable formachine-learning based models and algorithms. For example, the implantsurgery information can be tagged with particular identifiers forformulas or can be converted into numerical representations suitable forsupplying to the trained machine learning model(s). The treatmentplanning module 118 can also store information regarding the patient'sanatomy, such as two- or three-dimensional images or models of theanatomy, and/or information regarding the biology, geometry, and/ormechanical properties of the anatomy. The anatomy information can beused to inform implant design and/or placement.

The treatment plan(s) generated by the treatment planning module 118 canbe transmitted via the communication network 104 to the client computingdevice 102 for output to a user (e.g., clinician, surgeon, healthcareprovider, patient). In some embodiments, the client computing device 102includes or is operably coupled to a display 122 for outputting thetreatment plan(s). The display 122 can include a graphical userinterface (GUI) for visually depicting various aspects of the treatmentplan(s). For example, the display 122 can show various aspects of asurgical procedure to be performed on the patient, such as the surgicalapproach, treatment levels, corrective maneuvers, tissue resection,and/or implant placement. To facilitate visualization, a virtual modelof the surgical procedure can be displayed. As another example, thedisplay 122 can show a design for a medical device to be implanted inthe patient, such as a two- or three-dimensional model of the devicedesign. The display 122 can also show patient information, such as two-or three-dimensional images or models of the patient's anatomy where thesurgical procedure is to be performed and/or where the device is to beimplanted. The client computing device 102 can further include one ormore user input devices (not shown) allowing the user to modify, select,approve, and/or reject the displayed treatment plan(s).

In some embodiments, the medical device design(s) generated by thetreatment planning module 118 can be transmitted from the clientcomputing device 102 and/or server 106 to a manufacturing system 124 formanufacturing a corresponding medical device. The manufacturing system124 can be located on site or off site. On-site manufacturing can reducethe number of sessions with a patient and/or the time to be able toperform the surgery whereas off-site manufacturing can be useful makethe complex devices. Off-site manufacturing facilities can havespecialized manufacturing equipment. In some embodiments, morecomplicated device components can be manufactured off site, whilesimpler device components can be manufactured on site.

Various types of manufacturing systems are suitable for use inaccordance with the embodiments herein. For example, the manufacturingsystem 124 can be configured for additive manufacturing, such asthree-dimensional (3D) printing, stereolithography (SLA), digital lightprocessing (DLP), fused deposition modeling (FDM), selective lasersintering (SLS), selective laser melting (SLM), selective heat sintering(SHM), electronic beam melting (EBM), laminated object manufacturing(LOM), powder bed printing (PP), thermoplastic printing, direct materialdeposition (DMD), inkjet photo resin printing, or like technologies, orcombination thereof. Alternatively or in combination, the manufacturingsystem 124 can be configured for subtractive (traditional)manufacturing, such as CNC machining, electrical discharge machining(EDM), grinding, laser cutting, water jet machining, manual machining(e.g., milling, lathe/turning), or like technologies, or combinationsthereof. The manufacturing system 124 can manufacture one or morepatient-specific medical devices based on fabrication instructions ordata (e.g., CAD data, 3D data, digital blueprints, stereolithographydata, or other data suitable for the various manufacturing technologiesdescribed herein). Different components of the system 100 can generateat least a portion of the manufacturing data used by the manufacturingsystem 124. The manufacturing data can include, without limitation,fabrication instructions (e.g., programs executable by additivemanufacturing equipment, subtractive manufacturing equipment, etc.), 3Ddata, CAD data (e.g., CAD files), CAM data (e.g., CAM files), path data(e.g., print head paths, tool paths, etc.), material data, tolerancedata, surface finish data (e.g., surface roughness data), regulatorydata (e.g., FDA requirements, reimbursement data, etc.), or the like.The manufacturing system 124 can analyze the manufacturability of theimplant design based on the received manufacturing data. The implantdesign can be finalized by altering geometries, surfaces, etc. and thengenerating manufacturing instructions. In some embodiments, the server106 generates at least a portion of the manufacturing data, which istransmitted to the manufacturing system 124.

The manufacturing system 124 can generate CAM data, print data (e.g.,powder bed print data, thermoplastic print data, photo resin data,etc.), or the like and can include additive manufacturing equipment,subtractive manufacturing equipment, thermal processing equipment, orthe like. The additive manufacturing equipment can be 3D printers,stereolithography devices, digital light processing devices, fuseddeposition modeling devices, selective laser sintering devices,selective laser melting devices, electronic beam melting devices,laminated object manufacturing devices, powder bed printers,thermoplastic printers, direct material deposition devices, or inkjetphoto resin printers, or like technologies. The subtractivemanufacturing equipment can be CNC machines, electrical dischargemachines, grinders, laser cutters, water jet machines, manual machines(e.g., milling machines, lathes, etc.), or like technologies. Bothadditive and subtractive techniques can be used to produce implants withcomplex geometries, surface finishes, material properties, etc. Thegenerated fabrication instructions can be configured to cause themanufacturing system 124 to manufacture the patient-specific orthopedicimplant that matches or is therapeutically the same as thepatient-specific design. In some embodiments, the patient-specificmedical device can include features, materials, and designs sharedacross designs to simplify manufacturing. For example, deployablepatient-specific medical devices for different patients can have similarinternal deployment mechanisms but have different deployedconfigurations. In some embodiments, the components of thepatient-specific medical devices are selected from a set of availablepre-fabricated components and the selected pre-fabricated components canbe modified based on the fabrication instructions or data.

The treatment plans described herein can be performed by a surgeon, asurgical robot, or a combination thereof, thus allowing for treatmentflexibility. In some embodiments, the surgical procedure can beperformed entirely by a surgeon, entirely by a surgical robot, or acombination thereof. For example, one step of a surgical procedure canbe manually performed by a surgeon and another step of the procedure canbe performed by a surgical robot. In some embodiments the treatmentplanning module 118 generates control instructions configured to cause asurgical robot (e.g., robotic surgery systems, navigation systems, etc.)to partially or fully perform a surgical procedure. The controlinstructions can be transmitted to the robotic apparatus by the clientcomputing device 102 and/or the server 106.

Following the treatment of the patient in accordance with the treatmentplan, treatment progress can be monitored over one or more time periodsto update the data analysis module 116 and/or treatment planning module118. Post-treatment data can be added to the reference data stored inthe database 110. The post-treatment data can be used to train machinelearning models for developing patient-specific treatment plans,patient-specific medical devices, or combinations thereof.

It shall be appreciated that the components of the system 100 can beconfigured in many different ways. For example, in alternativeembodiments, the database 110, the data analysis module 116 and/or thetreatment planning module 118 can be components of the client computingdevice 102, rather than the server 106. As another example, the database110 the data analysis module 116, and/or the treatment planning module118 can be located across a plurality of different servers, computingsystems, or other types of cloud-computing resources, rather than at asingle server 106 or client computing device 102.

Additionally, in some embodiments, the system 100 can be operationalwith numerous other computing system environments or configurations.Examples of computing systems, environments, and/or configurations thatmay be suitable for use with the technology include, but are not limitedto, personal computers, server computers, handheld or laptop devices,cellular telephones, wearable electronics, tablet devices,multiprocessor systems, microprocessor-based systems, programmableconsumer electronics, network PCs, minicomputers, mainframe computers,distributed computing environments that include any of the above systemsor devices, or the like.

FIG. 2 illustrates a computing device 200 suitable for use in connectionwith the system 100 of FIG. 1, according to an embodiment. The computingdevice 200 can be incorporated in various components of the system 100of FIG. 1, such as the client computing device 102 or the server 106.The computing device 200 includes one or more processors 210 (e.g.,CPU(s), GPU(s), HPU(s), etc.). The processor(s) 210 can be a singleprocessing unit or multiple processing units in a device or distributedacross multiple devices. The processor(s) 210 can be coupled to otherhardware devices, for example, with the use of a bus, such as a PCI busor SCSI bus. The processor(s) 210 can be configured to execute one morecomputer-readable program instructions, such as program instructions tocarry out of any of the methods described herein.

The computing device 200 can include one or more input devices 220 thatprovide input to the processor(s) 210, e.g., to notify it of actionsfrom a user of the device 200. The actions can be mediated by a hardwarecontroller that interprets the signals received from the input deviceand communicates the information to the processor(s) 210 using acommunication protocol. Input device(s) 220 can include, for example, amouse, a keyboard, a touchscreen, an infrared sensor, a touchpad, awearable input device, a camera- or image-based input device, amicrophone, or other user input devices.

The computing device 200 can include a display 230 used to displayvarious types of output, such as text, models, virtual procedures,surgical plans, implants, graphics, and/or images (e.g., images withvoxels indicating radiodensity units or Hounsfield units representingthe density of the tissue at a location). In some embodiments, thedisplay 230 provides graphical and textual visual feedback to a user.The processor(s) 210 can communicate with the display 230 via a hardwarecontroller for devices. In some embodiments, the display 230 includesthe input device(s) 220 as part of the display 230, such as when theinput device(s) 220 include a touchscreen or is equipped with an eyedirection monitoring system. In alternative embodiments, the display 230is separate from the input device(s) 220. Examples of display devicesinclude an LCD display screen, an LED display screen, a projected,holographic, or augmented reality display (e.g., a heads-up displaydevice or a head-mounted device), and so on.

Optionally, other I/O devices 240 can also be coupled to theprocessor(s) 210, such as a network card, video card, audio card, USB,firewire or other external device, camera, printer, speakers, CD-ROMdrive, DVD drive, disk drive, or Blu-Ray device. Other I/O devices 240can also include input ports for information from directly connectedmedical equipment such as imaging apparatuses, including MRI machines,X-Ray machines, CT machines, etc. Other I/O devices 240 can furtherinclude input ports for receiving data from these types of machine fromother sources, such as across a network or from previously captureddata, for example, stored in a database.

In some embodiments, the computing device 200 also includes acommunication device (not shown) capable of communicating wirelessly orwire-based with a network node. The communication device can communicatewith another device or a server through a network using, for example,TCP/IP protocols. The computing device 200 can utilize the communicationdevice to distribute operations across multiple network devices,including imaging equipment, manufacturing equipment, etc.

The computing device 200 can include memory 250, which can be in asingle device or distributed across multiple devices. Memory 250includes one or more of various hardware devices for volatile andnon-volatile storage, and can include both read-only and writablememory. For example, a memory can comprise random access memory (RAM),various caches, CPU registers, read-only memory (ROM), and writablenon-volatile memory, such as flash memory, hard drives, floppy disks,CDs, DVDs, magnetic storage devices, tape drives, device buffers, and soforth. A memory is not a propagating signal divorced from underlyinghardware; a memory is thus non-transitory. In some embodiments, thememory 250 is a non-transitory computer-readable storage medium thatstores, for example, programs, software, data, or the like. In someembodiments, memory 250 can include program memory 260 that storesprograms and software, such as an operating system 262, one or moretreatment assistance modules 264, and other application programs 266.The treatment assistance module(s) 264 can include one or more modulesconfigured to perform the various methods described herein (e.g., thedata analysis module 116 and/or treatment planning module 118 describedwith respect to FIG. 1). Memory 250 can also include data memory 270that can include, e.g., reference data, configuration data, settings,user options or preferences, etc., which can be provided to the programmemory 260 or any other element of the computing device 200.

FIG. 3 is a flow diagram illustrating a method 300 for providingpatient-specific medical care, according to an embodiment. The method300 can include a data phase 310, a modeling phase 320, and an executionphase 330. The data phase 310 can include collecting data of a patientto be treated (e.g., pathology data), and comparing the patient data toreference data (e.g., prior patient data such as pathology, surgical,and/or outcome data). For example, a patient data set can be received(block 312). The patient data set can be compared to a plurality ofreference patient data sets (block 314), e.g., in order to identify oneor more similar patient data sets in the plurality of reference patientdata sets. Each of the plurality of reference patient data sets caninclude data representing one or more of age, gender, BMI, lumbarlordosis, Cobb angle(s), pelvic incidence, disc height, segmentflexibility, bone quality, rotational displacement, or treatment levelof the spine.

A subset of the plurality of reference patient data sets can be selected(block 316), e.g., based on similarity to the patient data set and/ortreatment outcomes of the corresponding reference patients. For example,a similarity score can be generated for each reference patient data set,based on the comparison of the patient data set and the referencepatient data set. The similarity score can represent a statisticalcorrelation between the patient data and the reference patient data set.One or more similar patient data sets can be identified based, at leastpartly, on the similarity score.

In some embodiments, each patient data set of the selected subsetincludes and/or is associated with data indicative of a favorabletreatment outcome (e.g., a favorable treatment outcome based on a singletarget outcome, aggregate outcome score, outcome thresholding). The datacan include, for example, data representing one or more of correctedanatomical metrics, presence of fusion, health related quality of life,activity level, or complications. In some embodiments, the data is orincludes an outcome score, which can be calculated based on a singletarget outcome, an aggregate outcome, and/or an outcome threshold.

Optionally, the data analysis phase 310 can include identifying ordetermining, for at least one patient data set of the selected subset(e.g., for at least one similar patient data set), surgical proceduredata and/or medical device design data associated with the favorabletreatment outcome. The surgical procedure data can include datarepresenting one or more of a surgical approach, a corrective maneuver,a bony resection, or implant placement. The at least one medical devicedesign can include data representing one or more of physical properties,mechanical properties, or biological properties of a correspondingmedical device. In some embodiments, the at least one patient-specificmedical device design includes a design for an implant or an implantdelivery instrument.

In the modeling phase 320, a surgical procedure and/or medical devicedesign is generated (block 322). The generating step can includedeveloping at least one predictive model based on the patient data setand/or selected subset of reference patient data sets (e.g., usingstatistics, machine learning, neural networks, AI, or the like). Thepredictive model can be configured to generate the surgical procedureand/or medical device design.

In some embodiments, the predictive model includes one or more trainedmachine learning models that generate, at least partly, the surgicalprocedure and/or medical device design. For example, the trained machinelearning model(s) can determine a plurality of candidate surgicalprocedures and/or medical device designs for treating the patient. Eachsurgical procedure can be associated with a corresponding medical devicedesign. In some embodiments, the surgical procedures and/or medicaldevice designs are determined based on surgical procedure data and/ormedical device design data associated with favorable outcomes, aspreviously described with respect to the data analysis phase 310. Foreach surgical procedure and/or corresponding medical device design, thetrained machine learning model(s) can calculate a probability ofachieving a target outcome (e.g., favorable or desired outcome) for thepatient. The trained machine learning model(s) can then select at leastone surgical procedure and/or corresponding medical device design based,at least partly, on the calculated probabilities.

The execution phase 330 can include manufacturing the medical devicedesign (block 332). In some embodiments, the medical device design ismanufactured by a manufacturing system configured to perform one or moreof additive manufacturing, 3D printing, stereolithography, digital lightprocessing, fused deposition modeling, selective laser sintering,selective laser melting, electronic beam melting, laminated objectmanufacturing, powder bed printing, thermoplastic printing, directmaterial deposition, or inkjet photo resin printing. The execution phase330 can optionally include generating fabrication instructionsconfigured to cause the manufacturing system to manufacture a medicaldevice having the medical device design.

The execution phase 330 can include performing the surgical procedure(block 334). The surgical procedure can involve implanting a medicaldevice having the medical device design into the patient. The surgicalprocedure can be performed manually, by a surgical robot, or acombination thereof. In embodiments where the surgical procedure isperformed by a surgical robot, the execution phase 330 can includegenerating control instructions configured to cause the surgical robotto perform, at least partly, the patient-specific surgical procedure.

The method 300 can be implemented and performed in various ways. In someembodiments, one or more steps of the method 300 (e.g., the data phase310 and/or the modeling phase 320) can be implemented ascomputer-readable instructions stored in memory and executable by one ormore processors of any of the computing devices and systems describedherein (e.g., the system 100), or a component thereof (e.g., the clientcomputing device 102 and/or the server 106). Alternatively, one or moresteps of the method 300 (e.g., the execution phase 330) can be performedby a healthcare provider (e.g., physician, surgeon), a robotic apparatus(e.g., a surgical robot), a manufacturing system (e.g., manufacturingsystem 124), or a combination thereof. In some embodiments, one or moresteps of the method 300 are omitted (e.g., the execution phase 330).

FIGS. 4A-4C illustrate exemplary data sets that may be used and/orgenerated in connection with the methods described herein (e.g., thedata analysis phase 310 described with respect to FIG. 3), according toan embodiment. FIG. 4A illustrates a patient data set 400 of a patientto be treated. The patient data set 400 can include a patient ID and aplurality of pre-operative patient metrics (e.g., age, gender, BMI,lumbar lordosis (LL), pelvic incidence (PI), and treatment levels of thespine (levels)). FIG. 4B illustrates a plurality of reference patientdata sets 410. In the depicted embodiment, the reference patient datasets 410 include a first subset 412 from a study group (Study Group X),a second subset 414 from a practice database (Practice Y), and a thirdsubset 416 from an academic group (University Z). In alternativeembodiments, the reference patient data sets 410 can include data fromother sources, as previously described herein. Each reference patientdata set can include a patient ID, a plurality of pre-operative patientmetrics (e.g., age, gender, BMI, lumbar lordosis (LL), pelvic incidence(PI), and treatment levels of the spine (levels)), treatment outcomedata (Outcome) (e.g., presence of fusion (fused), HRQL, complications),and treatment procedure data (Surg. Intervention) (e.g., implant design,implant placement, surgical approach).

FIG. 4C illustrates comparison of the patient data set 400 to thereference patient data sets 410. As previously described, the patientdata set 400 can be compared to the reference patient data sets 410 toidentify one or more similar patient data sets from the referencepatient data sets. In some embodiments, the patient metrics from thereference patient data sets 410 are converted to numeric values andcompared the patient metrics from the patient data set 400 to calculatea similarity score 420 (“Pre-op Similarity”) for each reference patientdata set. Reference patient data sets having a similarity score below athreshold value can be considered to be similar to the patient data set400. For example, in the depicted embodiment, reference patient data set410 a has a similarity score of 9, reference patient data set 410 b hasa similarity score of 2, reference patient data set 410 c has asimilarity score of 5, and reference patient data set 410 d has asimilarity score of 8. Because each of these scores are below thethreshold value of 10, reference patient data sets 410 a-d areidentified as being similar patient data sets.

The treatment outcome data of the similar patient data sets 410 a-d canbe analyzed to determine surgical procedures and/or implant designs withthe highest probabilities of success. For example, the treatment outcomedata for each reference patient data set can be converted to a numericaloutcome score 430 (“Outcome Quotient”) representing the likelihood of afavorable outcome. In the depicted embodiment, reference patient dataset 410 a has an outcome score of 1, reference patient data set 410 bhas an outcome score of 1, reference patient data set 410 c has anoutcome score of 9, and reference patient data set 410 d has an outcomescore of 2. In embodiments where a lower outcome score correlates to ahigher likelihood of a favorable outcome, reference patient data sets410 a, 410 b, and 410 d can be selected. The treatment procedure datafrom the selected reference patient data sets 410 a, 410 b, and 410 dcan then be used to determine at least one surgical procedure (e.g.,implant placement, surgical approach) and/or implant design that islikely to produce a favorable outcome for the patient to be treated.

In some embodiments, a method for providing medical care to a patient isprovided. The method can include comparing a patient data set toreference data. The patient data set and reference data can include anyof the data types described herein. The method can include identifyingand/or selecting relevant reference data (e.g., data relevant totreatment of the patient, such as data of similar patients and/or dataof similar treatment procedures), using any of the techniques describedherein. A treatment plan can be generated based on the selected data,using any of the techniques described herein. The treatment plan caninclude one or more treatment procedures (e.g., surgical procedures,instructions for procedures, models or other virtual representations ofprocedures), one or more medical devices (e.g., implanted devices,instruments for delivering devices, surgical kits), or a combinationthereof.

In some embodiments, a system for generating a medical treatment plan isprovided. The system can compare a patient data set to a plurality ofreference patient data sets, using any of the techniques describedherein. A subset of the plurality of reference patient data sets can beselected, e.g., based on similarity and/or treatment outcome, or anyother technique as described herein. A medical treatment plan can begenerated based at least in part on the selected subset, using any ofthe techniques described herein. The medical treatment plan can includeone or more treatment procedures, one or more medical devices, or any ofthe other aspects of a treatment plan described herein, or combinationsthereof.

In further embodiments, a system is configured to use historical patientdata. The system can select historical patient data to develop or selecta treatment plan, design medical devices, or the like. Historical datacan be selected based on one or more similarities between the presentpatient and prior patients to develop a prescriptive treatment plandesigned for desired outcomes. The prescriptive treatment plan can betailored for the present patient to increase the likelihood of thedesired outcome. In some embodiments, the system can analyze and/orselect a subset of historical data to generate one or more treatmentprocedures, one or more medical devices, or a combination thereof. Insome embodiments, the system can use subsets of data from one or moregroups of prior patients, with favorable outcomes, to produce areference historical data set used to, for example, design, develop orselect the treatment plan, medical devices, or combinations thereof.

FIG. 5 is a flow diagram illustrating a method 500 for providingpatient-specific medical care, according to another embodiment of thepresent technology. The method 500 can begin in step 502 by receiving apatient data set for a particular patient in need of medical treatment.The patient data set can include data representative of the patient'scondition, anatomy, pathology, symptoms, medical history, preferences,and/or any other information or parameters relevant to the patient. Forexample, the patient data set 808 can include surgical interventiondata, treatment outcome data, progress data (e.g., surgeon notes),patient feedback (e.g., feedback acquired using quality of lifequestionnaires, surveys), clinical data, patient information (e.g.,demographics, sex, age, height, weight, type of pathology, occupation,activity level, tissue information, health rating, comorbidities, healthrelated quality of life (HRQL)), vital signs, diagnostic results,medication information, allergies, diagnostic equipment information(e.g., manufacturer, model number, specifications, user-selectedsettings/configurations, etc.) or the like. The patient data set canalso include image data, such as camera images, Magnetic ResonanceImaging (MRI) images, ultrasound images, Computerized Aided Tomography(CAT) scan images, Positron Emission Tomography (PET) images, X-Rayimages, and the like. In some embodiments, the patient data set includesdata representing one or more of patient identification number (ID),age, gender, body mass index (BMI), lumbar lordosis, Cobb angle(s),pelvic incidence, disc height, segment flexibility, bone quality,rotational displacement, and/or treatment level of the spine. Thepatient data set can be received at a server, computing device, or othercomputing system. For example, in some embodiments the patient data setcan be received by the server 106 shown in FIG. 1 or the computingsystem 606 described below with respect to FIG. 6. In some embodiments,the computing system that receives the patient data set in step 502 alsostores one or more software modules (e.g., the data analysis module 116and/or the treatment planning module 118, shown in FIG. 1, or additionalsoftware modules for performing various operations of the method 500).Additional details for collecting and receiving the patient data set aredescribed below with respect to FIGS. 6-7D.

In some embodiments, the received patient data set can include diseasemetrics such as lumbar lordosis, Cobb angles, coronal parameters (e.g.,coronal balance, global coronal balance, coronal pelvic tilt, etc.),sagittal parameters (e.g., pelvic incidence, sacral slope, thoracickyphosis, etc.) and/or pelvic parameters. The disease metrics caninclude micro-measurements (e.g., metrics associated with specific orindividual segments of the patient's spine) and/or macro-measurements(e.g., metrics associated with multiple segments of the patient'sspine). In some embodiments, the disease metrics are not included in thepatient data set, and the method 500 includes determining (e.g.,automatically determining) one or more of the disease metrics based onthe patient image data, as described below.

Once the patient data set is received in step 502, the method 500 cancontinue in step 503 by creating a virtual model of the patient's nativeanatomical configuration (also referred to as “pre-operative anatomicalconfiguration”). The virtual model can be based on the image dataincluded in the patient data set received in step 502. For example, thesame computing system that received the patient data set in step 502 cananalyze the image data in the patient data set to generate a virtualmodel of the patient's native anatomical configuration. The virtualmodel can be a two- or three-dimensional visual representation of thepatient's native anatomy. The virtual model can include one or moreregions of interest, and may include some or all of the patient'sanatomy within the regions of interest (e.g., any combination of tissuetypes including, but not limited to, bony structures, cartilage, softtissue, vascular tissue, nervous tissue, etc.). As a non-limitingexample, the virtual model can include a visual representation of thepatient's spinal cord region, including some or all of the sacrum,lumbar region, thoracic region, and/or cervical region. In someembodiments, the virtual model includes soft tissue, cartilage, andother non-bony structures. In other embodiments, the virtual model onlyincludes the patient's bony structures. An example of a virtual model ofthe native anatomical configuration is described below with respect toFIGS. 8A and 8B. In some embodiments, the method 500 can optionally omitcreating a virtual model of the patient's native anatomy in step 503,and proceed directly from step 502 to step 504.

In some embodiments, the computing system that generated the virtualmodel in step 502 can also determine (e.g., automatically determine ormeasure) one or more disease metrics of the patient based on the virtualmodel. For example, the computing system may analyze the virtual modelto determine the patient's pre-operative lumbar lordosis, Cobb angles,coronal parameters (e.g., coronal balance, global coronal balance,coronal pelvic tilt, etc.), sagittal parameters (e.g., pelvic incidence,sacral slope, thoracic kyphosis, etc.) and/or pelvic parameters. Thedisease metrics can include micro-measurements (e.g., metrics associatedwith specific or individual segments of the patient's spine) and/ormacro-measurements (e.g., metrics associated with multiple segments ofthe patient's spine).

The method 500 can continue in step 504 by creating a virtual model of acorrected anatomical configuration (which can also be referred to hereinas the “planned configuration,” “optimized geometry,” “post-operativeanatomical configuration,” or “target outcome”) for the patient. Forexample, the computing system can, using the analysis proceduresdescribed previously, determine a “corrected” or “optimized” anatomicalconfiguration for the particular patient that represents an idealsurgical outcome for the particular patient. This can be done, forexample, by analyzing a plurality of reference patient data sets toidentify post-operative anatomical configurations for similar patientswho had a favorable post-operative outcome, as previously described indetail with respect to FIGS. 1-4C (e.g., based on similarity of thereference patient data set to the patient data set and/or whether thereference patient had a favorable treatment outcome). This may alsoinclude applying one or more mathematical rules defining optimalanatomical outcomes (e.g., positional relationships between anatomicelements) and/or target (e.g., acceptable) post-operative metrics/designcriteria (e.g., adjust anatomy so that the post-operative sagittalvertical axis is less than 7 mm, the post-operative Cobb angle less than10 degrees, etc.). Target post-operative metrics can include, but arenot limited to, target coronal parameters, target sagittal parameters,target pelvic incidence angle, target Cobb angle, target shoulder tilt,target iliolumbar angle, target coronal balance, target Cobb angle,target lordosis angle, and/or a target intervertebral space height. Thedifferent between the native anatomical configuration and the correctedanatomical configuration may be referred to as a “patient-specificcorrection” or “target correction.”

Once the corrected anatomical configuration is determined, the computingsystem can generate a two- or three-dimensional visual representation ofthe patient's anatomy with the corrected anatomical configuration. Aswith the virtual model created in step 503, the virtual model of thepatient's corrected anatomical configuration can include one or moreregions of interest, and may include some or all of the patient'sanatomy within the regions of interest (e.g., any combination of tissuetypes including, but not limited to, bony structures, cartilage, softtissue, vascular tissue, nervous tissue, etc.). As a non-limitingexample, the virtual model can include a visual representation of thepatient's spinal cord region in a corrected anatomical configuration,including some or all of the sacrum, lumbar region, thoracic region,and/or cervical region. In some embodiments, the virtual model includessoft tissue, cartilage, and other non-bony structures. In otherembodiments, the virtual model only includes the patient's bonystructures. An example of a virtual model of the native anatomicalconfiguration is described below with respect to FIGS. 9A-1-9B-2.

The method 500 can continue in step 506 by generating (e.g.,automatically generating) a surgical plan for achieving the correctedanatomical configuration shown by the virtual model. The surgical plancan include pre-operative plans, operative plans, post-operative plans,and/or specific spine metrics associated with the optimal surgicaloutcome. For example, the surgical plans can include a specific surgicalprocedure for achieving the corrected anatomical configuration. In thecontext of spinal surgery, the surgical plan may include a specificfusion surgery (e.g., PLIF, ALIF, TLIF, LLIF, DLIF, XLIF, etc.) across aspecific range of vertebral levels (e.g., L1-L4, L1-5, L3-T12, etc.). Ofcourse, other surgical procedures may be identified for achieving thecorrected anatomical configuration, such as non-fusion surgicalapproaches and orthopedic procedures for other areas of the patient. Thesurgical plan may also include one or more expected spine metrics (e.g.,lumbar lordosis, Cobb angles, coronal parameters, sagittal parameters,and/or pelvic parameters) corresponding to the expected post-operativepatient anatomy. The surgical plan can be generated by the same ordifferent computing system that created the virtual model of thecorrected anatomical configuration. In some embodiments, the surgicalplan can also be based on one or more reference patient data sets aspreviously described with respect to FIGS. 1-4C. In some embodiments,the surgical plan can also be based at least in part on surgeon-specificpreferences and/or outcomes associated with a specific surgeonperforming the surgery. In some embodiments, more than one surgical planis generated in step 506 to provide a surgeon with multiple options. Anexample of a surgical plan is described below with respect to FIG. 10.

After the virtual model of the corrected anatomical configuration iscreated in step 504 and the surgical plan is generated in step 506, themethod 500 can continue in step 508 by transmitting the virtual model ofthe corrected anatomical configuration and the surgical plan for surgeonreview. In some embodiments, the virtual model and the surgical plan aretransmitted as a surgical plan report, an example of which is describedwith respect to FIG. 11. In some embodiments, the same computing systemused in steps 502-506 can transmit the virtual model and surgical planto a computing device for surgeon review (e.g., the client computingdevice 102 described in FIG. 1 or the computing device 602 describedbelow with respect to FIG. 6). This can include directly transmittingthe virtual model and the surgical plan to the computing device oruploading the virtual model and the surgical plan to a cloud or otherstorage system for subsequent downloading. Although step 508 describestransmitting the surgical plan and the virtual model to the surgeon, oneskilled in the art will appreciate from the disclosure herein thatimages of the virtual model may be included in the surgical plantransmitted to the surgeon, and that the actual model need not beincluded (e.g., to decrease the file size being transmitted).Additionally, the information transmitted to the surgeon in step 508 mayinclude the virtual model of the patient's native anatomicalconfiguration (or images thereof) in addition to the virtual model ofthe corrected anatomical configuration. In embodiments in which morethan one surgical plan is generated in step 506, the method 500 caninclude transmitting more than one surgical plan to the surgeon forreview and selection.

The surgeon can review the virtual model and surgical plan and, in step510, either approve or reject the surgical plan (or, if more than onesurgical plan is provided in step 508, select one of the providedsurgical plans). If the surgeon does not approve the surgical plan instep 510, the surgeon can optionally provide feedback and/or suggestedmodifications to the surgical plan (e.g., by adjusting the virtual modelor changing one or more aspects about the plan). Accordingly, the method500 can include receiving (e.g., via the computing system) the surgeonfeedback and/or suggested modifications. If surgeon feedback and/orsuggested modifications are received in step 512, the method 500 cancontinue in step 514 by revising (e.g., automatically revising via thecomputing system) the virtual model and/or surgical plan based at leastin part on the surgeon feedback and/or suggested modifications receivedin step 512. In some embodiments, the surgeon does not provide feedbackand/or suggested modifications if they reject the surgical plan. In suchembodiments, step 512 can be omitted, and the method 500 can continue instep 514 by revising (e.g., automatically revising via the computingsystem) the virtual model and/or the surgical plan by selecting newand/or additional reference patient data sets. The revised virtual modeland/or surgical plan can then be transmitted to the surgeon for review.Steps 508, 510, 512, and 514 can be repeated as many times as necessaryuntil the surgeon approves the surgical plan. Although described as thesurgeon reviewing, modifying, approving, and/or rejecting the surgicalplan, in some embodiments the surgeon can also review, modify, approve,and/or reject the corrected anatomical configuration shown via thevirtual model.

Once surgeon approval of the surgical plan is received in step 510, themethod 500 can continue in step 516 by designing (e.g., via the samecomputing system that performed steps 502-514) a patient-specificimplant based on the corrected anatomical configuration and the surgicalplan. For example, the patient-specific implant can be specificallydesigned such that, when it is implanted in the particular patient, itdirects the patient's anatomy to occupy the corrected anatomicalconfiguration (e.g., transforming the patient's anatomy from the nativeanatomical configuration to the corrected anatomical configuration). Thepatient-specific implant can be designed such that, when implanted, itcauses the patient's anatomy to occupy the corrected anatomicalconfiguration for the expected service life of the implant (e.g., 5years or more, 10 years or more, 20 years or more, 50 years or more,etc.). In some embodiments, the patient-specific implant is designedsolely based on the virtual model of the corrected anatomicalconfiguration and/or without reference to pre-operative patient images.

The patient-specific implant can be any of the implants described hereinor in any patent references incorporated by reference herein. Forexample, the patient-specific implant can include one or more of screws(e.g., bone screws, spinal screws, pedicle screws, facet screws),interbody implant devices (e.g., intervertebral implants), cages,plates, rods, discs, fusion devices, spacers, rods, expandable devices,stents, brackets, ties, scaffolds, fixation device, anchors, nuts,bolts, rivets, connectors, tethers, fasteners, joint replacements (e.g.,artificial discs), hip implants, or the like. A patient-specific implantdesign can include data representing one or more of physical properties(e.g., size, shape, volume, material, mass, weight), mechanicalproperties (e.g., stiffness, strength, modulus, hardness), and/orbiological properties (e.g., osteo-integration, cellular adhesion,anti-bacterial properties, anti-viral properties) of the implant. Forexample, a design for an orthopedic implant can include implant shape,size, material, and/or effective stiffness (e.g., lattice density,number of struts, location of struts, etc.). An example of apatient-specific implant designed via the method 500 is described belowwith respect to FIGS. 12A and 12B.

In some embodiments, designing the implant in step 516 can optionallyinclude generating fabrication instructions for manufacturing theimplant. For example, the computing system may generatecomputer-executable fabrication instructions that that, when executed bya manufacturing system, cause the manufacturing system to manufacturethe implant.

In some embodiments, the patient-specific implant is designed in step516 only after the surgeon has reviewed and approved the virtual modelwith the corrected anatomical configuration and the surgical plan.Accordingly, in some embodiments, the implant design is neithertransmitted to the surgeon with the surgical plan in step 508, normanufactured before receiving surgeon approval of the surgical plan.Without being bound by theory, waiting to design the patient-specificimplant until after the surgeon approves the surgical plan may increasethe efficiency of the method 500 and/or reduce the resources necessaryto perform the method 500.

The method 500 can continue in step 518 by manufacturing thepatient-specific implant. The implant can be manufactured using additivemanufacturing techniques, such as 3D printing, stereolithography,digital light processing, fused deposition modeling, selective lasersintering, selective laser melting, electronic beam melting, laminatedobject manufacturing, powder bed printing, thermoplastic printing,direct material deposition, or inkjet photo resin printing, or liketechnologies, or combination thereof. Alternatively or additionally, theimplant can be manufactured using subtractive manufacturing techniques,such as CNC machining, electrical discharge machining (EDM), grinding,laser cutting, water jet machining, manual machining (e.g., milling,lathe/turning), or like technologies, or combinations thereof. Theimplant may be manufactured by any suitable manufacturing system (e.g.,the manufacturing system 124 shown in FIG. 1 or the manufacturing system630 described below with respect to FIG. 6). In some embodiments, theimplant is manufactured by the manufacturing system executing thecomputer-readable fabrication instructions generated by the computingsystem in step 516.

Once the implant is manufactured in step 518, the method 500 cancontinue in step 520 by implanting the patient-specific implant into thepatient. The surgical procedure can be performed manually, by a roboticsurgical platform (e.g., a surgical robot), or a combination thereof. Inembodiments in which the surgical procedure is performed at least inpart by a robotic surgical platform, the surgical plan can includecomputer-readable control instructions configured to cause the surgicalrobot to perform, at least partly, the patient-specific surgicalprocedure. Additional details regarding a robotic surgical platform aredescribed below with respect to FIG. 6.

The method 500 can be implemented and performed in various ways. In someembodiments, steps 502-516 can be performed by a computing system (e.g.,the computing system 606 described below with respect to FIG. 6)associated with a first entity, step 518 can be performed by amanufacturing system associated with a second entity, and step 520 canbe performed by a surgical provider, surgeon, and/or robotic surgicalplatform associated with a third entity. Any of the foregoing steps mayalso be implemented as computer-readable instructions stored in memoryand executable by one or more processors of the associated computingsystem(s).

FIG. 6 is a schematic illustration of an operative setup includingselect systems and devices that can be used to provide patient-specificmedical care, such as for performing the method 500 described withrespect to FIG. 5. As shown, the operative setup includes a computingdevice 602, a computing system 606, a cloud 608, a manufacturing system630, and a robotic surgical platform 650. The computing device 602 canbe a user device, such as a smart phone, mobile device, laptop, desktop,personal computer, tablet, phablet, or other such devices known in theart. In operation, a user (e.g., a surgeon) can collect, retrieve,review, modify, or otherwise interact with a patient data set using thecomputing device 602. The computing system 606 can include any suitablecomputing system configured to store one or more software modules foridentifying reference patient data sets, determining patient-specificsurgical plans, generating virtual models of patient anatomy, designingpatient-specific implants, or the like. The one or more software modulescan include algorithms, machine-learning models, artificial intelligencearchitectures, or the like for performing select operations. The cloud608 can be any suitable network and/or storage system, and may includeany combination of hardware and/or virtual computing resources. Themanufacturing system 630 can be any suitable manufacturing system forproducing patient-specific implants, including any of those previouslydescribed herein. The robotic surgical platform 650 (referred to hereinas “the platform 650”) can be configured to perform or otherwise assistwith one or more aspects of a surgical procedure.

In a representative operation, the computing device 602, the computingsystem 606, the cloud 608, the manufacturing system 630, and theplatform 650 can be used to provide patient-specific medical care, suchas to perform the method 500 described with respect to FIG. 5. Forexample, the computing system 606 can receive a patient data set fromthe computing device 602 (e.g., step 502 of the method 500). In someembodiments, the computing device 602 can directly transmit the patientdata set to the computing system 606. In other embodiments, thecomputing device 602 can upload the patient data set into the cloud 608,and the computing system 606 can download or otherwise access thepatient data set from the cloud. Once the computing system 606 receivesthe patient data set, the computing system 606 can create a virtualmodel of the patient's native anatomical configuration (e.g., step 503of the method 500), create a virtual model of the corrected anatomicalconfiguration (e.g., step 504 of the method 500), and/or generate asurgical plan for achieving the corrected anatomical configuration(e.g., step 506 of the method 500). The computing system can perform theforegoing operations via the one or more software modules, which in someembodiments include machine learning models or other artificialintelligence architectures. Once the virtual models and the surgicalplan are created, the computing system 606 can transmit the virtualmodels and the surgical plan to the surgeon for review (e.g., step 508of the method 500). This can include, for example, directly transmittingthe virtual models and the surgical plan to the computing device 602 forsurgeon review. In other embodiments, this can include uploading thevirtual models and the surgical plan to the cloud 608. A surgeon canthen download or otherwise access the virtual models and the surgicalplan from the cloud 608 using the computing device 602.

The surgeon can use the computing device 602 to review the virtualmodels and the surgical plan. The surgeon can also approve or reject thesurgical plan and provide any feedback regarding the surgical plan usingthe computing device 602. The surgeon's approval, rejection, and/orfeedback regarding the surgical plan can be transmitted to, and receivedby, the computing system 606 (e.g., steps 510 and 512 of the method500). The computing system 606 can than revise the virtual model and/orthe surgical plan (e.g., step 514 of the method 500). The computingsystem 606 can transmit the revised virtual model and surgical plan tothe surgeon for review (e.g., by uploading it to the cloud 608 ordirectly transmitting it to the computing device 602).

The computing system 606 can also design the patient-specific implantbased on the corrected anatomical configuration and the surgical plan(e.g., step 516 of the method 500) using, the one or more softwaremodules. In some embodiments, software modules rely on one or morealgorithms, machine learning models, or other artificial intelligencearchitectures to design the implant. Once the computing system 606designs the patient-specific implant, the computing system 606 canupload the design and/or manufacturing instructions to the cloud 608.The computing system 606 may also create fabrication instructions (e.g.,computer-readable fabrication instructions) for manufacturing thepatient-specific implant. In such embodiments, the computing system 606can upload the fabrication instructions to the cloud 608.

The manufacturing system 630 can download or otherwise access the designand/or fabrication instructions for the patient-specific implant fromthe cloud 608. The manufacturing system can then manufacture thepatient-specific implant (e.g., step 518 in the method 500) usingadditive manufacturing techniques, subtractive manufacturing techniques,or other suitable manufacturing techniques.

The robotic surgical platform 650 can perform or otherwise assist withone or more aspects of the surgical procedure (e.g., step 520 of themethod 500). For example, the platform 650 can prepare tissue for anincision, make an incision, make a resection, remove tissue, manipulatetissue, perform a corrective maneuver, deliver the implant to a targetsite, deploy the implant at the target site, adjust the implant at thetarget site, manipulate the implant once it is implanted, secure theimplant at the target site, explant the implant, suture tissue, etc. Theplatform 650 can therefore include one or more arms 655 and endeffectors for holding various surgical tools (e.g., graspers, clips,needles, needle drivers, irrigation tools, suction tools, staplers,screw driver assemblies, etc.), imaging instruments (e.g., cameras,sensors, etc.), and/or medical devices (e.g., the implant 600) and thatenable the platform 650 to perform the one or more aspects of thesurgical plan. Although shown as having one arm 655, one skilled in theart will appreciate that the platform 650 can have a plurality of arms(e.g., two, three, four, or more) and any number of joints, linkages,motors, and degrees of freedom. In some embodiments, the platform 650may have a first arm dedicated to holding one or more imaginginstruments, while the remainder of the arms hold various surgicaltools. In some embodiments, the tools can be releasably secured to thearms such that they can be selectively interchanged before, during, orafter an operative procedure. The arms can be moveable through a varietyof ranges of motion (e.g., degrees of freedom) to provide adequatedexterity for performing various aspects of the operative procedure.

The platform 650 can include a control module 660 for controllingoperation of the arm(s) 655. In some embodiments, the control module 660includes a user input device (not shown) for controlling operation ofthe arm(s) 655. The user input device can be a joystick, a mouse, akeyboard, a touchscreen, an infrared sensor, a touchpad, a wearableinput device, a camera- or image-based input device, a microphone, orother user input devices. A user (e.g., a surgeon) can interact with theuser input device to control movement of the arm(s) 655.

In some embodiments, the control module 660 includes one or moreprocessors for executing machine-readable operative instructions that,when executed, automatically control operation of the arm 655 to performone or more aspects of the surgical procedure. In some embodiments, thecontrol module 660 may receive the machine-readable operativeinstructions (e.g., from the cloud 608) specifying one or more steps ofthe surgical procedure that, when executed by the control module 660,cause the platform 650 to perform the one or more steps of the surgicalprocedure. For example, the machine-readable operative instructions maydirect the platform 650 to prepare tissue for an incision, make anincision, make a resection, remove tissue, manipulate tissue, perform acorrective maneuver, deliver the implant 600 to a target site, deploythe implant 600 at the target site, adjust a configuration of theimplant 600 at the target site, manipulate the implant 600 once it isimplanted, secure the implant 600 at the target site, explant theimplant 600, suture tissue, and the like. The operative instructions maytherefor include particular instructions for articulating the arm 655 toperform or otherwise aid in the delivery of the patient-specificimplant.

In some embodiments, the platform 650 can generate (e.g., as opposed tosimply receiving) the machine-readable operative instructions based onthe surgical plan. For example, the surgical plan can includeinformation about the delivery path, tools, and implantation site. Theplatform 650 can analyze the surgical plan and develop executableoperative instructions for performing the patient-specific procedurebased on the capabilities (e.g., configuration and number of roboticarms, functionality of and effectors, guidance systems, visualizationsystems, etc.) of the robotic system. This enables the operative setupshown in FIG. 6 to be compatible with a wide range of different types ofrobotic surgery systems.

The platform 650 can include one or more communication devices (e.g.,components having VLC, WiMAX, LTE, WLAN, IR communication, PSTN, Radiowaves, Bluetooth, and/or Wi-Fi operability) for establishing aconnection with the cloud 608 and/or the computing device 602 foraccessing and/or downloading the surgical plan and/or themachine-readable operative instructions. For example, the cloud 608 canreceive a request for a particular surgical plan from the platform 650and send the plan to the platform 650. Once identified, the cloud 608can transmit the surgical plan directly to the platform 650 forexecution. In some embodiments, the cloud 608 can transmit the surgicalplan to one or more intermediate networked devices (e.g., the computingdevice 602) rather than transmitting the surgical plan directly to theplatform 650. A user can review the surgical plan using the computingdevice 602 before transmitting the surgical plan to the platform 650 forexecution. Additional details for identifying, storing, downloading, andaccessing patient-specific surgical plans are described in U.S.application Ser. No. 16/990,810, filed Aug. 11, 2020, the disclosure ofwhich is incorporated by reference herein in its entirety.

The platform 650 can include additional components not expressly shownin FIG. 6. For example, in various embodiments the platform 650 mayinclude one or more displays (e.g., LCD display screen, an LED displayscreen, a projected, holographic, or augmented reality display (e.g., aheads-up display device or a head-mounted device), one or more I/Odevices (e.g., a network card, video card, audio card, USB, firewire orother external device, camera, printer, speakers, CD-ROM drive, DVDdrive, disk drive, or Blu-Ray device), and/or a memory (e.g., randomaccess memory (RAM), various caches, CPU registers, read-only memory(ROM), and writable non-volatile memory, such as flash memory, harddrives, floppy disks, CDs, DVDs, magnetic storage devices, tape drives,device buffers, and so forth). In some embodiments, the foregoingcomponents can be generally similar to the like components described indetail with respect to computing device 200 in FIG. 2.

Without being bound by theory, using a robotic surgical platform toperform various aspects of the surgical plans described herein isexpected to provide several advantages over conventional operativetechniques. For example, use of robotic surgical platforms may improvesurgical outcomes and/or shorten recovery times by, for example,decreasing incision size, decreasing blood loss, decreasing a length oftime of the operative procedure, increasing the accuracy and precisionof the surgery (e.g., the placement of the implant at the targetlocation), and the like. The platform 650 can also avoid or reduce userinput errors, e.g., by including one or more scanners for obtaininginformation from instruments (e.g., instruments with retrievalfeatures), tools, the patient specific implant 600 (e.g., after theimplant 600 has been gripped by the arm 655), etc. The platform 650 canconfirm use of proper instruments prior and during the surgicalprocedure. If the platform 650 identifies an incorrect instrument ortool, an alert can be sent to a user that another instrument or toolshould be installed. The user can scan the new instrument to confirmthat the instrument is appropriate for the surgical plan. In someembodiments, the surgical plan includes instructions for use, a list ofinstruments, instrument specifications, replacement instruments, and thelike. The platform 650 can perform pre- and post-surgical checkingroutines based on information from the scanners.

FIGS. 7A-13 further illustrate select aspects of providingpatient-specific medical care, e.g., in accordance with the method 500.For example, FIG. 7A-7D illustrate an example of a patient data set 700(e.g., as received in step 502 of the method 500). The patient data set700 can include any of the information previously described with respectto the patient data set. For example, the patient data set 700 includespatient information 701 (e.g., patient identification no., patient MRN,patient name, sex, age, body mass index (BMI), surgery date, surgeon,etc., shown in FIGS. 7A and 7B), diagnostic information 702 (e.g.,Oswestry Disability Index (ODI), VAS-back score, VAS-leg score,Pre-operative pelvic incidence, pre-operative lumbar lordosis,pre-operative PI-LL angel, pre-operative lumbar coronal cobb, etc.,shown in FIGS. 7B and 7C), and image data 703 (x-ray, CT, MRI, etc.,shown in FIGS. 7D). In the illustrated embodiment, the patient data set700 is collected by a healthcare provider (e.g., a surgeon, a nurse,etc.) using a digital and/or fillable report that can be accessed usinga computing device (e.g., the computing device 602 shown in FIG. 6). Insome embodiments, the patient data set 700 can be automatically or atleast partially automatically generated based on digital medical recordsof the patient. Regardless, once collected, the patient data set 700 canbe transmitted to the computing system configured to generate thesurgical plan for the patient (e.g., the computing system 606 shown inFIG. 6).

FIGS. 8A and 8B illustrate an example of a virtual model 800 of apatient's native anatomical configuration (e.g., as created in step 503of the method 500). In particular, FIG. 8A is an enlarged view of thevirtual model 800 of the patient's native anatomy and shows thepatient's native anatomy of their lower spinal cord region. The virtualmodel 800 is a three-dimensional visual representation of the patient'snative anatomy. In the illustrated embodiment, the virtual modelincludes a portion of the spinal column extending from the sacrum to theL4 vertebral level. Of course, the virtual model can include otherregions of the patient's spinal column, including cervical vertebrae,thoracic vertebrae, lumbar vertebrae, and the sacrum. The illustratedvirtual model 800 only includes bony structures of the patient'sanatomy, but in other embodiments may include additional structures,such as cartilage, soft tissue, vascular tissue, nervous tissue, etc.

FIG. 8B illustrates a virtual model display 850 (referred to herein asthe “display 850”) showing different views of the virtual model 800. Thevirtual model display 850 includes a three-dimensional view of thevirtual model 800, one or more coronal cross-section(s) 802 of thevirtual model 800, one or more axial cross section(s) 804 of the virtualmodel 800, and/or one or more sagittal cross-section(s) 806 of thevirtual model 800. Of course, other views are possible and can beincluded on the virtual model display 850. In some embodiments, thevirtual model 800 may be interactive such that a user can manipulate theorientation or view of the virtual model 800 (e.g., rotate), change thedepth of the displayed cross-sections, select and isolate specific bonystructures, or the like.

FIGS. 9A-1-9B-2 demonstrate an example of a virtual model of a patient'snative anatomical configuration (e.g., as created in step 503 of themethod 500) and a virtual model of the patient's corrected anatomicalconfiguration (e.g., as created in step 504 of the method 500). Inparticular, FIGS. 9A-1 and 9A-2 are anterior and lateral views,respectively, of a virtual model 910 showing a native anatomicalconfiguration of a patient, and FIGS. 9B-1 and 9B-2 are anterior andlateral views, respectively, of a virtual model 920 showing thecorrected anatomical configuration for the same patient. Referring firstto FIG. 9A-1, the anterior view of the virtual model 910 illustrates thepatient has abnormal curvature (e.g., scoliosis) of their spinal column.This is marked by line X, which follows a rostral-caudal axis of thespinal column. Referring next to FIG. 9A-1, the lateral view of thevirtual model 910 illustrates the patient has collapsed discs ordecreased spacing between adjacent vertebral endplates, marked by ovalsY. FIGS. 9B-1 and 9B-2 illustrate the corrected virtual model 920accounting for the abnormal anatomical configurations shown in FIGS.9A-1 and 9A-2. For example, FIG. 9B-1, which is an anterior view of thevirtual model 920, illustrates the patient's spinal column havingcorrected alignment (e.g., the abnormal curvature has been reduced).This correction is shown by line X, which also follows a rostral-caudalaxis of the spinal column. FIG. 9B-2, which is a lateral view of thevirtual model 920, illustrates the patient's spinal column havingrestored disc height (e.g., increased spacing between adjacent vertebralendplates), also marked by ovals Y. The lines X and the ovals Y areprovided in FIGS. 9A-1-9B-2 to more clearly demonstrate the correctionbetween the virtual models 910 and 920, and are not necessarily includedon the virtual models generated in accordance with the presenttechnology.

FIG. 10 illustrates an example of a surgical plan 1000 (e.g., asgenerated in step 506 of the method 500). The surgical plan 1000 caninclude pre-operative patient metrics 1002, predicted post-operativepatient metrics 1004, one or more patient images (e.g., the patientimages 703 received as part of the patient data set), the virtual model910 (which can be the model itself or one or more images derived fromthe model) of the patient's native anatomical configuration (e.g.,pre-operative patient anatomy), and/or the virtual model 920 (which canbe the model itself or one or more images derived from the model) of thepatient's corrected anatomical configuration (e.g., predictedpost-operative patient anatomy). The virtual model 920 of the predictedpost-operative patient anatomy can optionally include one or moreimplants 1012 shown as implanted in the patient's spinal cord region todemonstrate how patient anatomy will look following the surgery.Although four implants 1012 are shown in the virtual model 920, thesurgical plan 1000 may include more or fewer implants 1012, includingone, two, three, five, six, seven, eight, or more implants 1012.

The surgical plan 1000 can include additional information beyond what isillustrated in FIG. 10. For example, the surgical plan 1000 may includepre-operative instructions, operative instructions, and/orpost-operative instructions. Operative instructions can include one ormore specific procedures to be performed (e.g., PLIF, ALIF, TLIF, LLIF,DLIF, XLIF, etc.) and/or one or more specific targets of the operation(e.g., fusion of vertebral levels L1-L4, anchoring screw to be insertedin lateral surface of L4, etc.). Although the surgical plan 1000 isdemonstrated in FIG. 10 as a visual report, the surgical plan 1000 canalso be encoded in computer-executable instructions that, when executedby a processor connected to a computing device, cause the surgical plan1000 to be displayed by the computing device. In some embodiments, thesurgical plan 1000 may also include machine-readable operativeinstructions for carrying out the surgical plan. For example, thesurgical plan can include operative instructions for a robotic surgicalplatform to carry out one or more steps of the surgical plan 1000.

FIG. 11 provides a series of images illustrating an example of a patientsurgical plan report 1100 that includes the surgical plan 1000 and thatmay be transmitted to a surgeon for review and approval (e.g., astransmitted in step 508 of the method 500). The surgical plan report1100 can include a multi-page report detailing aspects of the surgicalplan 1000. For example, the multi-page report may include a first page1101 demonstrating an overview of the surgical plan 1000 (e.g., as shownin FIG. 10), a second page 1102 illustrating patient images (e.g., suchas the patient images 703 received in step 502 and shown in FIG. 7D), athird page 1103 illustrating an enlarged view of the virtual model ofthe corrected anatomical configuration (e.g., the virtual model 920shown in FIG. 9), and a fourth page 1104 prompting the surgeon to eitherapprove or reject the surgical plan 900. Of course, additionalinformation about the surgical plan can be presented with the report1100 in the same or different formats. In some embodiments, if thesurgeon rejects the surgical plan 1000, the surgeon can be prompted toprovide feedback regarding the aspects of the surgical plan 1000 thesurgeon would like adjusted.

The patient surgical plan report 1100 can be presented to the surgeon ona digital display of a computing device (e.g., the client computingdevice 102 shown in FIG. 1 or the computing device 602 shown in FIG. 6).In some embodiments, the report 1100 is interactive and the surgeon canmanipulate various aspects of the report 1100 (e.g., adjust views of thevirtual model, zoom-in, zoom-out, annotate, etc.). However, even if thereport 1100 is interactive, the surgeon generally cannot directly changethe surgical plan 1000. Rather, the surgeon may provide feedback andsuggested changes to the surgical plan 1000, which can be sent back tothe computing system that generated the surgical plan 1000 for analysisand refinement.

FIG. 12A illustrates an example of a patient-specific implant 1200(e.g., as designed in step 516 and manufactured in step 518 of themethod 500), and FIG. 12B illustrates the implant 1200 implanted in thepatient. The implant 1200 can be any orthopedic or other implantspecifically designed to induce the patient's body to conform to thepreviously identified corrected anatomical configuration. In theillustrated embodiment, the implant 1200 is an vertebral interbodydevice having a first (e.g., upper) surface 1202 configured to engage aninferior endplate surface of a superior vertebral body and a second(e.g., lower) surface 1204 configured to engage a superior endplatesurface of an inferior vertebral body. The first surface 1202 can have apatient-specific topography designed to match (e.g., mate with) thetopography of the inferior endplate surface of the superior vertebralbody to form a generally gapless interface therebetween. Likewise, thesecond surface 1204 can have a patient-specific topography designed tomatch or mate with the topography of the superior endplate surface ofthe inferior vertebral body to form a generally gapless interfacetherebetween. The implant 1200 may also include a recess 1206 or otherfeature configured to promote bony ingrowth. Because the implant 1200 ispatient-specific and designed to induce a geometric change in thepatient, the implant 1200 is not necessarily symmetric, and is oftenasymmetric. For example, in the illustrated embodiment, the implant 1200has a non-uniform thickness such that a plane defined by the firstsurface 1202 is not parallel to a central longitudinal axis A of theimplant 1200. Of course, because the implants described herein,including the implant 1200, are patient-specific, the present technologyis not limited to any particular implant design or characteristic.Additional features of patient-specific implants that can be designedand manufactured in accordance with the present technology are describedin U.S. patent application Ser. Nos. 16/987,113 and 17/100,396, thedisclosures of which are incorporated by reference herein in theirentireties.

The patient-specific medical procedures described herein can involveimplanting more than one patient-specific implant into the patient toachieve the corrected anatomical configuration (e.g., a multi-siteprocedure). FIG. 13, for example, illustrates a lower spinal cord regionhaving three patient specific implants 1300 a-1300 c implanted atdifferent vertebral levels. More specifically, a first implant 1300 a isimplanted between the L3 and L4 vertebral bodies, a second implant 1300b is implanted between the L4 and L5 vertebral bodies, and a thirdimplant 1300 c is implanted between the L5 vertebral body and thesacrum. Together, the implants 1300 a-c can cause the patient's spinalcord region to assume the previously identified corrected anatomicalconfiguration (e.g., transforming the patient's anatomy from itspre-operative diseased configuration to the post-operative optimizedconfiguration). In some embodiments, more or fewer implants are used toachieve the corrected anatomical configuration. For example, in someembodiments one, two, four, five, six, seven, eight, or more implantsare used to achieve the corrected anatomical configuration. Inembodiments involving more than one implant, the implants do notnecessarily have the same shape, size, or function. In fact, themultiple implants will often have different geometries and topographiesto correspond to the target vertebral level at which they will beimplanted. As also shown in FIG. 13, the patient-specific medicalprocedures described herein can involve treating the patient at multipletarget regions (e.g., multiple vertebral levels).

In addition to designing patient-specific medical care based offreference patient data sets, the systems and methods of the presenttechnology may also design patient-specific medical care based offdisease progression for a particular patient. In some embodiments, thepresent technology therefore includes software modules (e.g., machinelearning models or other algorithms) that can be used to analyze,predict, and/or model disease progression for a particular patient. Themachine learning models can be trained based off a plurality ofreference patient data sets that includes, in addition to the patientdata described with respect to FIG. 1, disease progression metrics foreach of the reference patients. The progression metrics can includemeasurements for disease metrics over a period of time. Suitable metricsmay include spinopelvic parameters (e.g., lumbar lordosis, pelvic tilt,sagittal vertical axis (SVA), cobb angel, coronal offset, etc.),disability scores, functional ability scores, flexibility scores, VASpain scores, or the like. The progression of the metrics for eachreference patient can be correlated to other patient information for thespecific reference patient (e.g., age, sex, height, weight, activitylevel, diet, etc.).

In some embodiments, the present technology includes a diseaseprogression module that includes an algorithm, machine learning model,or other software analytical tool for predicting disease progression ina particular patient. The disease progression module can be trainedbased on reference patient data sets that includes patient information(e.g., age, sex, height, weight, activity level, diet) and diseasemetrics (e.g., diagnosis, spinopelvic parameters such as lumbarlordosis, pelvic tilt, sagittal vertical axis, cobb angel, coronaloffset, etc., disability scores, functional ability scores, flexibilityscores, VAS pain scores, etc.). The disease metrics can include valuesover a period of time. For example, the reference patient data mayinclude values of disease metrics on a daily, weekly, monthly,bi-monthly, yearly, or other basis. By measuring the metrics over aperiod of time, changes in the values of the metrics can be tracked asan estimate of disease progression and correlated to other patient data.

In some embodiments, the disease progression module can thereforeestimate the rate of disease progression for a particular patient. Theprogression may be estimated by providing estimated changes in one ormore disease metrics over a period of time (e.g., X% increase in adisease metric per year). The rate can be constant (e.g., 5% increase inpelvic tilt per year) or variable (e.g., 5% increase in pelvic tilt fora first year, 10% increase in pelvic tilt for a second year, etc.). Insome embodiments, the estimated rate of progression can be transmittedto a surgeon or other healthcare provider, who can review and update theestimate, if necessary.

As a non-limiting example, a particular patient who is afifty-five-year-old male may have a SVA value of 6 mm. The diseaseprogression module can analyze patient reference data sets to identifydisease progression for individual reference patients have one or moresimilarities with the particular patient (e.g., individual patients ofthe reference patients who have an SVA value of about 6 mm and areapproximately the same age, weight, height, and/or sex of the patient).Based on this analysis, the disease progression module can predict therate of disease progression if no surgical intervention occurs (e.g.,the patient's VAS pain scores may increase 5%, 10%, or 15% annually ifno surgical intervention occurs, the SVA value may continue to increaseby 5% annually if no surgical intervention occurs, etc.).

The systems and methods described herein can also generatemodels/simulations based on the estimated rates of disease progression,thereby modeling different outcomes over a desired period of times.Additionally, the models/simulations can account for any number ofadditional diseases or condition to predict the patient's overallhealth, mobility, or the like. These additional diseases or conditionscan, in combination with other patient health factors (e.g., height,weight, age, activity level, etc.) be used to generate a patient healthscore reflecting the overall health of the patient. The patient healthscore can be displayed for surgeon review and/or incorporated into theestimation of disease progression. Accordingly, the present technologycan generate one or more virtual simulations of the predicted diseaseprogression to demonstrate how the patient's anatomy is predicted tochange over time. Physician input can be used to generate or modify thevirtual simulation(s). The present technology can generate one or morepost-treatment virtual simulations based on the received physician inputfor review by the healthcare provider, patient, etc.

In some embodiments, the present technology can also predict, model,and/or simulate disease progression based on one or more potentialsurgical interventions. For example, the disease progression module maysimulate what a patient's anatomy may look like 1, 2, 5, or 10 yearspost-surgery for several surgical intervention options. The simulationsmay also incorporate non-surgical factors, such as patient age, height,weight, sex, activity level, other health conditions, or the like, aspreviously described. Based on these simulations, the system and/or asurgeon can select which surgical intervention is best suited forlong-term efficacy. These simulations can also be used to determinepatient-specific corrections that compensate for the projected diseasesprogression.

Accordingly, in some embodiments, multiple disease progression models(e.g., two, three, four, five, six, or more) are simulated to providedisease progression data for several different surgical interventionoptions or other scenarios. For example, the disease progression modulecan generate models that predict post-surgical disease progression foreach of three different surgical interventions. A surgeon or otherhealthcare provider can review the disease progression models and, basedon the review, select which of the three surgical intervention optionsis likely to provide the patient with the best long-term outcome. Ofcourse, selecting the optimal intervention can also be fully orsemi-automated, as described herein.

Based off of the modeled disease progression, the systems and methodsdescribed herein can also (i) identify the optimal time for surgicalintervention, and/or (ii) identify the optimal type of surgicalprocedure for the patient. In some embodiments, the present technologytherefore includes an intervention timing module that includes analgorithm, machine learning model, or other software analytical tool fordetermining the optimal time for surgical intervention in a particularpatient. This can be done, for example, by analyzing patient referencedata that includes (i) pre-operative disease progression metrics forindividual reference patients, (ii) disease metrics at the time ofsurgical intervention for individual reference patients, (iii)post-operative disease progression metrics for individual referencepatients, and/or (iv) scored surgical outcomes for individual referencepatients. The intervention timing module can compare the disease metricsfor a particular patient to the reference patient data sets todetermine, for similar patients, the point of disease progression atwhich surgical intervention produced the most favorable outcomes.

As a non-limiting example, the reference patient data sets may includedata associated with reference patients' sagittal vertical axis. Thedata can include (i) sagittal vertical axis values for individualpatients over a period of time before surgical intervention (e.g., howfast and to what degree the sagittal vertical axis value changed), (ii)sagittal vertical axis of the individual patients at the time ofsurgical intervention, (iii) the change in sagittal vertical axis aftersurgical intervention, and (iv) the degree to which the surgicalintervention was successful (e.g., based on pain, quality of life, orother factors). Based on the foregoing data, the intervention timingmodule can, based on a particular patient's sagittal vertical axisvalue, identify at which point surgical intervention will have thehighest likelihood of producing the most favorable outcome. Of course,the foregoing metric is provided by way of example only, and theintervention timing module can incorporate other metrics (e.g., lumbarlordosis, pelvic tilt, sagittal vertical axis, cobb angel, coronaloffset, disability scores, functional ability scores, flexibilityscores, VAS pain scores) instead of or in combination with sagittalvertical axis to predict the time at which surgical intervention has thehighest probability of providing a favorable outcome for the particularpatient.

The intervention timing module may also incorporate one or moremathematical rules based on value thresholds for various diseasemetrics. For example, the intervention timing module may indicatesurgical intervention is necessary if one or more disease metrics exceeda predetermined threshold or meet some other criteria. Representativethresholds that indicate surgical intervention may be necessary includeSVA values greater than 7 mm, a mismatch between lumbar lordosis andpelvic incidence greater than 10 degrees, a cobb angle of greater than10 degrees, and/or a combination of cobb angle and LL/PI mismatchgreater than 20 degrees. Of course, other threshold values and metricscan be used; the foregoing are provided as examples only and in no waylimit the present disclosure. In some embodiments, the foregoing rulescan be tailored to specific patient populations (e.g., for males over 50years of age, an SVA value greater than 7 mm indicates the need forsurgical intervention). If a particular patient does not exceed thethresholds indicating surgical intervention is recommended, theintervention timing module may provide an estimate for when thepatient's metrics will exceed one or more thresholds, thereby providingthe patient with an estimate of when surgical intervention may becomerecommended.

The present technology may also include a treatment planning module thatcan identify the optimal type of surgical procedure for the patientbased on the disease progression of the patient. The treatment planningmodule can be an algorithm, machine learning model, or other softwareanalytical tool trained or otherwise based on a plurality of referencepatient data sets, as previously described. The treatment planningmodule may also incorporate one or more mathematical rules foridentifying surgical procedures. As a non-limiting example, if a LL/PImismatch is between 10 and 20 degrees, the treatment planning module mayrecommend an anterior fusion surgery, but if the LL/PI mismatch isgreater than 20 degrees, the treatment planning module may recommendboth anterior and posterior fusion surgery. As another non-limitingexample, if a SVA value is between 7 mm and 15 mm, the treatmentplanning module may recommend posterior fusion surgery, but if the SVAis above 15 mm, the treatment planning module may recommend bothposterior fusion surgery and anterior fusion surgery. Of course, otherrules can be used; the foregoing are provided as examples only and in noway limit the present disclosure.

Without being bound by theory, incorporating disease progressionmodeling into the patient-specific medical procedures described hereinmay even further increase the effectiveness of the procedures. Forexample, in many cases it may be disadvantageous operate after apatient's disease progresses to an irreversible or unstable state.However, it may also be disadvantageous to operate too early, before thepatient's disease is causing symptoms and/or if the patient's diseasemay not progress further. The disease progression module and/or theintervention timing module can therefore help identify the window oftime during which surgical intervention in a particular patient has thehighest probability of providing a favorable outcome for the patient.

As one skilled in the art will appreciate, any of the software modulesdescribed previously may be combined into a single software module forperforming the operations described herein. Likewise, the softwaremodules can be distributed across any combination of the computingsystems and devices described herein, and are not limited to the expressarrangements described herein. Accordingly, any of the operationsdescribed herein can be performed by any of the computing devices orsystems described herein, unless expressly noted otherwise.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, or examples can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or virtually any combination thereof. In some embodiments,several portions of the subject matter described herein may beimplemented via Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Arrays (FPGAs), digital signal processors (DSPs), orother integrated formats. However, those skilled in the art willrecognize that some aspects of the embodiments disclosed herein, inwhole or in part, can be equivalently implemented in integratedcircuits, as one or more computer programs running on one or morecomputers (e.g., as one or more programs running on one or more computersystems), as one or more programs running on one or more processors(e.g., as one or more programs running on one or more microprocessors),as firmware, or as virtually any combination thereof, and that designingthe circuitry and/or writing the code for the software and or firmwarewould be well within the skill of one of skill in the art in light ofthis disclosure. In addition, those skilled in the art will appreciatethat the mechanisms of the subject matter described herein are capableof being distributed as a program product in a variety of forms, andthat an illustrative embodiment of the subject matter described hereinapplies regardless of the particular type of signal bearing medium usedto actually carry out the distribution. Examples of a signal bearingmedium include, but are not limited to, the following: a recordable typemedium such as a floppy disk, a hard disk drive, a CD, a DVD, a digitaltape, a computer memory, etc.; and a transmission type medium such as adigital and/or an analog communication medium (e.g., a fiber opticcable, a waveguide, a wired communications link, a wirelesscommunication link, etc.).

Those skilled in the art will recognize that it is common within the artto describe devices and/or processes in the fashion set forth herein,and thereafter use engineering practices to integrate such describeddevices and/or processes into data processing systems. That is, at leasta portion of the devices and/or processes described herein can beintegrated into a data processing system via a reasonable amount ofexperimentation. Those having skill in the art will recognize that atypical data processing system generally includes one or more of asystem unit housing, a video display device, a memory such as volatileand non-volatile memory, processors such as microprocessors and digitalsignal processors, computational entities such as operating systems,drivers, graphical user interfaces, and applications programs, one ormore interaction devices, such as a touch pad or screen, and/or controlsystems including feedback loops and control motors (e.g., feedback forsensing position and/or velocity; control motors for moving and/oradjusting components and/or quantities). A typical data processingsystem may be implemented utilizing any suitable commercially availablecomponents, such as those typically found in datacomputing/communication and/or network computing/communication systems.

The herein described subject matter sometimes illustrates differentcomponents contained within, or connected with, different othercomponents. It is to be understood that such depicted architectures aremerely examples, and that in fact many other architectures can beimplemented which achieve the same functionality. In a conceptual sense,any arrangement of components to achieve the same functionality iseffectively “associated” such that the desired functionality isachieved. Hence, any two components herein combined to achieve aparticular functionality can be seen as “associated with” each othersuch that the desired functionality is achieved, irrespective ofarchitectures or intermediate components. Likewise, any two componentsso associated can also be viewed as being “operably connected,” or“operably coupled,” to each other to achieve the desired functionality,and any two components capable of being so associated can also be viewedas being “operably couplable” to each other to achieve the desiredfunctionality. Specific examples of operably couplable include but arenot limited to physically mateable and/or physically interactingcomponents and/or wirelessly interactable and/or wirelessly interactingcomponents and/or logically interacting and/or logically interactablecomponents.

The embodiments, features, systems, devices, materials, methods andtechniques described herein may, in some embodiments, be similar to anyone or more of the embodiments, features, systems, devices, materials,methods and techniques described in the following:

U.S. application Ser. No. 16/048,167, filed on Jul. 27, 2017, titled“SYSTEMS AND METHODS FOR ASSISTING AND AUGMENTING SURGICAL PROCEDURES;”U.S. application Ser. No. 16/242,877, filed on Jan. 8, 2019, titled“SYSTEMS AND METHODS OF ASSISTING A SURGEON WITH SCREW PLACEMENT DURINGSPINAL SURGERY;”U.S. application Ser. No. 16/207,116, filed on Dec. 1, 2018, titled“SYSTEMS AND METHODS FOR MULTI-PLANAR ORTHOPEDIC ALIGNMENT;”U.S. application Ser. No. 16/352,699, filed on Mar.13, 2019, titled“SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION;”U.S. application Ser. No. 16/383,215, filed on Apr. 12, 2019, titled“SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANT FIXATION;”U.S. application Ser. No. 16/569,494, filed on Sep. 12, 2019, titled“SYSTEMS AND METHODS FOR ORTHOPEDIC IMPLANTS;” andU.S. Application No. 62/773,127, filed on Nov. 29, 2018, titled “SYSTEMSAND METHODS FOR ORTHOPEDIC IMPLANTS.”U.S. Application No. 62/928,909, filed on Oct. 31, 2019, titled “SYSTEMSAND METHODS FOR DESIGNING ORTHOPEDIC IMPLANTS BASED ON TISSUECHARACTERISTICS;”U.S. application Ser. No. 16/735,222 (now U.S. Pat. No. 10,902,944),filed Jan. 6, 2020, titled “PATIENT-SPECIFIC MEDICAL PROCEDURES ANDDEVICES, AND ASSOCIATED SYSTEMS AND METHODS;”U.S. application Ser. No. 16/987,113, filed Aug. 6, 2020, titled“PATIENT-SPECIFIC ARTIFICIAL DISCS, IMPLANTS AND ASSOCIATED SYSTEMS ANDMETHODS;”U.S. application Ser. No. 16/990,810, filed Aug. 11, 2020, titled“LINKING PATIENT-SPECIFIC MEDICAL DEVICES WITH PATIENT-SPECIFIC DATA,AND ASSOCIATED SYSTEMS, DEVICES, AND METHODS;”U.S. application Ser. No. 17/085,564, filed Oct. 30, 2020, titled“SYSTEMS AND METHODS FOR DESIGNING ORTHOPEDIC IMPLANTS BASED ON TISSUECHARACTERISTICS;”U.S. application Ser. No. 17/100,396, filed Nov. 20, 2020, titled“PATIENT-SPECIFIC VERTEBRAL IMPLANTS WITH POSITIONING FEATURES;”U.S. application Ser. No. 17/124,822, filed Dec. 17, 2020, titled“PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATED SYSTEMSAND METHODS;” andInternational Application No. PCT/US2021/012065, filed Jan. 4, 2021,titled “PATIENT-SPECIFIC MEDICAL PROCEDURES AND DEVICES, AND ASSOCIATEDSYSTEMS AND METHODS.”

All of the above-identified patents and applications are incorporated byreference in their entireties. In addition, the embodiments, features,systems, devices, materials, methods and techniques described hereinmay, in certain embodiments, be applied to or used in connection withany one or more of the embodiments, features, systems, devices, or othermatter.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” or the like includes thenumber recited. Numbers preceded by a term such as “approximately,”“about,” and “substantially” as used herein include the recited numbers(e.g., about 10%=10%), and also represent an amount close to the statedamount that still performs a desired function or achieves a desiredresult. For example, the terms “approximately,” “about,” and“substantially” may refer to an amount that is within less than 10% of,within less than 5% of, within less than 1% of, within less than 0.1%of, and within less than 0.01% of the stated amount.

From the foregoing, it will be appreciated that various embodiments ofthe present disclosure have been described herein for purposes ofillustration, and that various modifications may be made withoutdeparting from the scope and spirit of the present disclosure.Accordingly, the various embodiments disclosed herein are not intendedto be limiting.

1. A computer-implemented method for providing patient-specific medicalcare, the method comprising: receiving one or more images of a patient'sspinal region in a native anatomical configuration; creating athree-dimensional virtual model of the spinal region in the nativeanatomical configuration using computer aided design software, whereinthe three-dimensional virtual model is based on the one or more images;determining a corrected anatomical configuration for the patient'sspinal region based on one or more native spine metric values of thethree-dimensional virtual model; generating a correctedthree-dimensional virtual model of the patient's spinal region in thecorrected anatomical configuration; generating a surgical plan forachieving the corrected anatomical configuration; transmitting thesurgical plan for surgeon viewing; and after receiving surgeon approvalof the surgical plan, designing one or more patient-specific virtualintervertebral implants based on the corrected three-dimensional virtualmodel so as to achieve the corrected anatomical configuration.
 2. Thecomputer-implemented method of claim 1, further comprising: identifyingone or more implantation sites in the corrected three-dimensionalvirtual model of the patient's spinal region; and generating one or morecorrected spine metric values associated with the one or moreimplantation sites.
 3. The computer-implemented method of claim 1,further comprising receiving one or more adjusted spine metric values,wherein the corrected anatomical configuration of the patient's spinalregion is based on the received one or more adjusted spine metricvalues.
 4. The computer-implemented method of claim 1, wherein thecorrected three-dimensional virtual model is based on modifying thethree-dimensional virtual model of the spinal region in the nativeanatomical configuration according to one or more user-inputted adjustedspine metric values.
 5. The computer-implemented method of claim 1,further comprising (a) receiving feedback for the surgical plan, (b)revising the surgical plan based on the feedback, (c) transmitting therevised surgical plan for surgeon review, and (d) repeating steps(a)-(c) until receiving surgeon approval.
 6. The computer-implementedmethod of claim 1, wherein the corrected anatomical configuration isbased on one or more reference patient data sets.
 7. Thecomputer-implemented method of claim 1, further comprising generating aquantitative comparison of the patient's spinal region in the correctedanatomical configuration and in the native anatomical configuration. 8.The computer-implemented method of claim 1, further comprisinggenerating one or more images of the patient's spinal region in thecorrected anatomical configuration and in the native anatomicalconfiguration.
 9. The computer-implemented method of claim 1, whereinthe corrected three-dimensional virtual model has virtual vertebraerepresenting the patient's vertebrae in post-operative positions. 10.The computer-implemented method of claim 1, further comprisingtransmitting machine-readable fabrication instructions to amanufacturing system to enable the manufacturing system to manufactureone or more patient-specific intervertebral implants.
 11. Thecomputer-implemented method of claim 1, further comprising designing oneor more patient-specific virtual vertebral implants configured to seatagainst virtual vertebrae of the corrected three-dimensional virtualmodel.
 12. A system for providing patient-specific medical care, thesystem comprising: one or more processors; and a memory storinginstructions that, when executed by the one or more processors, causethe system to perform operations comprising: receiving one or moreimages of a patient's spinal region in a native anatomicalconfiguration; creating a three-dimensional virtual model of the spinalregion in the native anatomical configuration using computer aideddesign software, wherein the three-dimensional virtual model is based onthe one or more images; determining a corrected anatomical configurationfor the patient's spinal region based on one or more native spine metricvalues of the three-dimensional virtual model; generating a correctedthree-dimensional virtual model of the patient's spinal region in thecorrected anatomical configuration; generating a surgical plan forachieving the corrected anatomical configuration; transmitting thesurgical plan for surgeon viewing; and after receiving surgeon approvalof the surgical plan, designing one or more patient-specific virtualintervertebral implants based on the corrected three-dimensional virtualmodel so as to achieve the corrected anatomical configuration.
 13. Thesystem of claim 12, wherein the operations further include: identifyingone or more implantation sites in the corrected three-dimensionalvirtual model of the patient's spinal region; and generating one or morecorrected spine metric values associated with the one or moreimplantation sites.
 14. The system of claim 12, wherein the operationsfurther include receiving one or more adjusted spine metric values,wherein the corrected anatomical configuration of the patient's spinalregion is based on the received one or more adjusted spine metricvalues.
 15. The system of claim 12, wherein the operations furtherinclude generating a quantitative comparison of the patient's spinalregion in the corrected anatomical configuration and in the nativeanatomical configuration.
 16. The system of claim 12, wherein theoperations further include generating one or more images of thepatient's spinal region in the corrected anatomical configuration and inthe native anatomical configuration.
 17. A non-transitorycomputer-readable medium storing instructions that, when executed by acomputing system, cause the computing system to perform operationscomprising: receiving one or more images of a patient's spinal region ina native anatomical configuration; creating a three-dimensional virtualmodel of the spinal region in the native anatomical configuration usingcomputer aided design software, wherein the three-dimensional virtualmodel is based on the one or more images; determining a correctedanatomical configuration for the patient's spinal region based on one ormore native spine metric values of the three-dimensional virtual model;generating a corrected three-dimensional virtual model of the patient'sspinal region in the corrected anatomical configuration; generating asurgical plan for achieving the corrected anatomical configuration;transmitting the surgical plan for surgeon viewing; and after receivingsurgeon approval of the surgical plan, designing one or morepatient-specific virtual intervertebral implants based on the correctedthree-dimensional virtual model so as to achieve the correctedanatomical configuration.
 18. The non-transitory computer-readablemedium of claim 17, wherein the operations further include: identifyingone or more implantation sites in the corrected three-dimensionalvirtual model of the patient's spinal region; and generating one or morecorrected spine metric values associated with the one or moreimplantation sites.
 19. The non-transitory computer-readable medium ofclaim 17, wherein the operations further include receiving one or moreadjusted spine metric values, wherein the corrected anatomicalconfiguration of the patient's spinal region is based on the receivedone or more adjusted spine metric values.
 20. The non-transitorycomputer-readable medium of claim 17, wherein the operations furtherinclude generating a quantitative comparison of the patient's spinalregion in the corrected anatomical configuration and in the nativeanatomical configuration.
 21. The non-transitory computer-readablemedium of claim 17, wherein the operations further include generatingone or more images of the patient's spinal region in the correctedanatomical configuration and in the native anatomical configuration. 22.The computer-implemented method of claim 1, further comprising:manufacturing one or more patient-specific intervertebral implantsaccording to designs of the one or more patient-specific virtualintervertebral implants.
 23. A method of manufacturing one or morepatient-specific intervertebral implants for a patient, the methodcomprising: receiving fabrication data for the one or morepatient-specific intervertebral implants, wherein the fabrication datais generated by a process including: receiving one or more images of thepatient's spinal region in a native anatomical configuration; creating athree-dimensional virtual model of the spinal region in the nativeanatomical configuration using computer aided design software, whereinthe three-dimensional virtual model is based on the one or more images,determining a corrected anatomical configuration for the patient'sspinal region based on one or more native spine metric values of thethree-dimensional virtual model, generating a correctedthree-dimensional virtual model of the patient's spinal region in thecorrected anatomical configuration, generating a surgical plan forachieving the corrected anatomical configuration, transmitting thesurgical plan for surgeon viewing, and after receiving surgeon approvalof the surgical plan, designing one or more patient-specific virtualintervertebral implants based on the corrected three-dimensional virtualmodel so as to achieve the corrected anatomical configuration; andmanufacturing the one or more patient-specific intervertebral implantsbased on the received fabrication data.
 24. The method of claim 23,wherein the fabrication data includes designs of the one or morepatient-specific intervertebral implants, the method further comprises:generating fabrication instructions executable by at least one ofadditive manufacturing equipment or subtractive manufacturing equipment,wherein the fabrication instructions are based on manufacturability ofthe designs; and using the at least one of additive manufacturingequipment or subtractive manufacturing equipment to manufacture the oneor more patient-specific intervertebral implants according to thefabrication instructions.
 25. The method of claim 23, furthercomprising: modifying the fabrication data based on manufacturability ofthe one or more patient-specific intervertebral implants; generatingmanufacturing instructions based on the modified fabrication data; andtransmitting the manufacturing instructions to manufacturing equipment,wherein the manufacturing equipment executes the manufacturinginstructions to manufacture the one or more patient-specificintervertebral implants.
 26. The method of claim 25, wherein themanufacturing instructions include additive manufacturing data forautomated fabrication of the one or more patient-specific intervertebralimplants configured to therapeutically match their respective designs ofthe fabrication data.